Keysource Pharmaceuticals Jobs in Usa

Intra-Cellular Therapies Inc. a Johnson & Johnson (“J&J”) company is headquartered in Bedminster, NJ. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. We have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.

Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA® medical team to support our growing impact in psychiatry.

The Neuroscience Sales Specialist-II, has overall responsibility for meeting or exceeding sales expectations within their assigned geographies in an ethical and compliant manner. The sales specialist is responsible for understanding and identifying customer needs, aligning marketing resources and supporting pull-through activities. They are also accountable for embodying and communicating Intra-Cellular’s corporate vision of improving the lives of patients suffering from neuropsychiatric disorders.

The Neuroscience Sales Specialist-II will develop superior product and disease state knowledge that allows them to compliantly engage in in-depth clinical dialogue with healthcare professionals. Additionally, they will have responsibility for the creation of local strategic and tactical plans, differential resource allocation, and accountability for effective application of budget and expense management within their assigned territory.

We are looking for sales professionals who have a passion for patients, tenacity for results, ability to adapt and evolve, entrepreneurial thirst for working in an energizing and winning culture.

Job Responsibilities

• Following compliance guidelines, drives sales performance to ensure sales forecasts are met or exceeded within assigned territory by calling on HCP offices and Mental Health Community Centers both in-person and virtually.
• Effectively uses assigned budgets to achieve territory objectives. Customizes discussions and client interactions based on customer’s needs in a compliant and ethical manner
• Maintains current understanding of local market, practice structures, evolving customers, and key influencers. Routinely shares such information with relevant internal Intra-Cellular stakeholders.
• Provides input into resource allocation decisions across customers/region. Identifies and selects programs/resources available and appropriate for each customer, practice, and/or system.
• Works with Regional Business Manager and key stakeholders to develop a local business plan that ensures achievement of all business objectives. Capitalizes on formulary approvals and other business opportunities through effective implementation of the strategic plan.
• Collaborates with other Neuroscience Sales Specialists on common objectives and sharing of best practices.
• Accountable for providing timely and accurate administrative management of work hours, sales call data, customer objectives, communication responses, synchronization, sample and expense reporting.
• Effectively inform and build a business plan based on depth and breadth of customer business needs, resources and products.
• Complete all company and job-related training as assigned within the required timelines.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job Requirements

• 2+ years of previous sales experience in pharmaceuticals, biologics, or medical device sales required; 3+ years of sales experience in specialty pharmaceuticals preferred
• Launch, antipsychotic, and/or bi-polar sales experience highly preferred.
• Must have Bachelor’s degree from an accredited college or university as well as a valid driver’s license and safe driving record.
• Must have strong desire and passion for improving the lives of patients and their caregivers. Ideal candidate emulates patient-centricity.
• Must act with high integrity and always in accordance with the Company’s Compliance policies and procedures.
• Must have strong sense of self-motivation, initiative, and entrepreneurial thirst, excellent decision-making judgment, strong teaming/collaboration and cross-functional skills
• A proven track record of success in learning and adapting to an evolving environment such as Covid-19 in order to overcome obstacles and challenges
• Must have ability to be agile and adapt to the changing telemedicine/virtual environment.
• Ability to analyze data/metrics to assess progress against objectives as well as diagnose performance issues and identify new opportunities.
• Experience establishing new customer relationships and communicating technical information to a diverse customer audience.
• Work hours may include meetings scheduled outside of normal working hours.
• Territories may require some overnight travel depending on geography.
• Some domestic travel to corporate headquarters, training and sales meetings will also be required on a periodic basis.
• Must be able to perform all essential functions of the position, with or without reasonable accommodation.

#ITCIBuild2025

Salary range for this position: $98,000 - $155,000

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Skills:

Business Behavior, Clinical Experience, Coaching, Competitive Landscape Analysis, Cross-Functional Collaboration, Cultural Competence, Customer Centricity, Data Savvy, Developing Partnerships, Market Knowledge, Neuroscience, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Product Knowledge, Sales, Sales Enablement, Sales Trend Analysis, Strategic Sales Planning

At Afton Scientific, every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a Quality Control Supervisor to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia.

Overview of this Position:

The QC Analytical Chemistry Supervisor is responsible for the oversight, performance, and continuous improvement of analytical testing in support of pharmaceutical manufacturing operations. This role supervises daily QC laboratory activities, supports analytical staff, ensures adherence to pharmacopeial and regulatory requirements, and provides technical guidance on method execution, data integrity, and laboratory compliance. This position also contributes to method development and qualification, oversees laboratory instrumentation and maintenance schedules, participates in audits, and ensures accurate review and documentation of laboratory operations in alignment with FDA, ICH, USP, EU, and related quality expectations.

Non-Negotiable Requirements:

• Bachelor’s degree in chemistry or a closely related scientific discipline

•Minimum 5 years of experience in pharmaceutical analytical testing in a cGMP environment, including hands‑on operation of HPLC, GC, FTIR, KFT, UV‑Vis, and similar technologies

•Demonstrated experience in regulated laboratory settings (FDA/ICH/USP), including strong understanding of data integrity (ALCOA+) and cGMP compliance

•Proficiency in reviewing and approving laboratory documentation (SOPs, deviations, OOS/OOT/OOE/NCMR, protocols, reports)

•Strong background in chromatography and experience using Empower

•Experience with raw material testing, stability testing, and LIMS

•Strong written and verbal communication skills

Preferred Requirements:

• Experience supervising or mentoring laboratory personnel

• Experience supporting regulatory or client audits

•Strong technical troubleshooting abilities with analytical methods or laboratory equipment

Responsibilities Include:

• Develop, implement, and maintain HR policies and procedures to support organizational compliance •Supervise daily QC Analytical Chemistry Laboratory operations related to production support, testing activities, and staff oversight

•Provide guidance to laboratory staff and assist in the management and development of QC analytical personnel as directed by the QC Manager

•Execute and oversee cGMP‑compliant analysis of raw materials, APIs, and pharmaceutical finished products using pharmacopeial and regulatory methods (USP, NF, JP, EU, FDA, ICH)

•Ensure proper design, execution, documentation, and validation of analytical techniques, instrumentation, and test methods used in the laboratory

•Review executed laboratory operations for accuracy, completeness, and compliance with internal SOPs and external regulatory expectations

•Oversee equipment calibrations, verifications, and preventative maintenance activities for laboratory instrumentation and supporting equipment

•Identify technical issues and lead independent troubleshooting efforts, providing follow‑up and solutions to management as needed

•Participate in client and regulatory audits as a QC representative and maintain professional, prepared communication with external partners and internal teams

•Write, review, or approve SOPs, validation protocols, specifications, and investigation reports as applicable (e.g., OOS, OOT, ODR, NCMR)

•Assist with procurement of laboratory equipment and supplies and contribute to process improvements within the QC laboratory

The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We are an equal opportunity employer. We do not discriminate based on disability and will provide reasonable accommodation as required by law.

Job Title: Inside sales Pharmaceutical Representative

Salary: $60,000 USD per year

Incentive/Bonus: $12,000 USD annually + Uncapped Monthly Commission

Work Location: Chandler, AZ

Job Description

About Medivant Healthcare

Medivant Healthcare is a leading U.S.-based pharmaceutical manufacturing company specializing in high-quality generic injectable medications. We are committed to delivering reliable, accessible, and affordable healthcare solutions to hospitals, clinics, and pharmacies across the United States.

Position Overview:

Looking for a driven Inside Sales Pharmaceutical Representative who thrives on opening doors, creating opportunities, and owning results. This role is ideal for someone who enjoys hunting for new business while also managing and growing existing accounts.

Key Responsibilities:

• Proactively prospect and engage new healthcare accounts through outbound calls
• Manage a book of business with full ownership of account growth and retention
• Drive win-back conversations with inactive or lapsed accounts
• Build strong, trusted relationships with clinics, and healthcare partners
• Consistently meet or exceed daily activity, monthly revenue, and growth targets
• Maintain accurate documentation and pipeline activity in CRM ProGen
• Collaborate with leadership and cross-functional teams

A Day in the Life:

• Start the day reviewing priorities, forecasted orders, and follow-ups
• Make outbound calls to new prospects to introduce products and begin onboarding conversations
• Re-engage past or inactive accounts, addressing prior objections and identifying new opportunities
• Guide new customers through onboarding, pricing, and ordering to ensure smooth first experience
• Work your pipeline intentionally, moving opportunities forward and closing business
• End the day updating CRM activity and planning the next day’s outreach

Qualifications & Skills:

• Hunter mentality with a strong sense of urgency and accountability
• Experience in pharmaceutical, healthcare, medical device, or B2B inside sales preferred
• Comfortable with high-volume outbound calling and consultative sales conversations
• Strong closing skills with the ability to move opportunities forward
• Organized, disciplined, and able to manage priorities independently
• Confident communicator who can explain value clearly and professionally
• Resilient, competitive, and motivated by performance-based success

What We Offer:

• Competitive base salary plus commission
• Clear performance metrics and growth opportunities
• Supportive leadership with a strong team culture
• Opportunity to make a real impact in patient care and healthcare delivery

Intra-Cellular Therapies Inc. a Johnson & Johnson (“J&J”) company is headquartered in Bedminster, NJ. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. We have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.

Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA® medical team to support our growing impact in psychiatry.

The Neuroscience Sales Specialist-II, has overall responsibility for meeting or exceeding sales expectations within their assigned geographies in an ethical and compliant manner. The sales specialist is responsible for understanding and identifying customer needs, aligning marketing resources and supporting pull-through activities. They are also accountable for embodying and communicating Intra-Cellular’s corporate vision of improving the lives of patients suffering from neuropsychiatric disorders.

The Neuroscience Sales Specialist-II will develop superior product and disease state knowledge that allows them to compliantly engage in in-depth clinical dialogue with healthcare professionals. Additionally, they will have responsibility for the creation of local strategic and tactical plans, differential resource allocation, and accountability for effective application of budget and expense management within their assigned territory.

We are looking for sales professionals who have a passion for patients, tenacity for results, ability to adapt and evolve, entrepreneurial thirst for working in an energizing and winning culture.

Job Responsibilities

• Following compliance guidelines, drives sales performance to ensure sales forecasts are met or exceeded within assigned territory by calling on HCP offices and Mental Health Community Centers both in-person and virtually.
• Effectively uses assigned budgets to achieve territory objectives. Customizes discussions and client interactions based on customer’s needs in a compliant and ethical manner
• Maintains current understanding of local market, practice structures, evolving customers, and key influencers. Routinely shares such information with relevant internal Intra-Cellular stakeholders.
• Provides input into resource allocation decisions across customers/region. Identifies and selects programs/resources available and appropriate for each customer, practice, and/or system.
• Works with Regional Business Manager and key stakeholders to develop a local business plan that ensures achievement of all business objectives. Capitalizes on formulary approvals and other business opportunities through effective implementation of the strategic plan.
• Collaborates with other Neuroscience Sales Specialists on common objectives and sharing of best practices.
• Accountable for providing timely and accurate administrative management of work hours, sales call data, customer objectives, communication responses, synchronization, sample and expense reporting.
• Effectively inform and build a business plan based on depth and breadth of customer business needs, resources and products.
• Complete all company and job-related training as assigned within the required timelines.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job Requirements

• 2+ years of previous sales experience in pharmaceuticals, biologics, or medical device sales required; 3+ years of sales experience in specialty pharmaceuticals preferred
• Launch, antipsychotic, and/or bi-polar sales experience highly preferred.
• Must have Bachelor’s degree from an accredited college or university as well as a valid driver’s license and safe driving record.
• Must have strong desire and passion for improving the lives of patients and their caregivers. Ideal candidate emulates patient-centricity.
• Must act with high integrity and always in accordance with the Company’s Compliance policies and procedures.
• Must have strong sense of self-motivation, initiative, and entrepreneurial thirst, excellent decision-making judgment, strong teaming/collaboration and cross-functional skills
• A proven track record of success in learning and adapting to an evolving environment such as Covid-19 in order to overcome obstacles and challenges
• Must have ability to be agile and adapt to the changing telemedicine/virtual environment.
• Ability to analyze data/metrics to assess progress against objectives as well as diagnose performance issues and identify new opportunities.
• Experience establishing new customer relationships and communicating technical information to a diverse customer audience.
• Work hours may include meetings scheduled outside of normal working hours.
• Territories may require some overnight travel depending on geography.
• Some domestic travel to corporate headquarters, training and sales meetings will also be required on a periodic basis.
• Must be able to perform all essential functions of the position, with or without reasonable accommodation.

#ITCIBuild2025

Salary range for this position: $98,000 - $155,000

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Skills:

Business Behavior, Clinical Experience, Coaching, Competitive Landscape Analysis, Cross-Functional Collaboration, Cultural Competence, Customer Centricity, Data Savvy, Developing Partnerships, Market Knowledge, Neuroscience, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Product Knowledge, Sales, Sales Enablement, Sales Trend Analysis, Strategic Sales Planning

Director of Quality Assurance

Position Summary

The Director of Quality Assurance is responsible for leading a comprehensive range of quality assurance activities in support of Fortvita Biologics’ commercial, clinical, and development programs. This role serves as a strategic and tactical leader in quality initiatives, ensuring compliance with Good Clinical Practice (GCP) standards and overseeing the development, implementation, and continuous improvement of quality systems.

Key responsibilities include conducting GxP audits of both U.S. and international contract/service organizations—including, but not limited to, manufacturing facilities, Contract Research Organizations (CROs), and investigator sites. The Director will lead and coordinate investigations with external vendors and internal teams to address and resolve potential product quality issues.

Additionally, this position oversees the preparation, review, and disposition of internal and external documentation related to GxP activities, ensuring consistency, compliance, and quality throughout the organization’s operations. This role is onsite at the Palo Alto office.

Essential Functions

• Provide quality leadership and oversight for multiple clinical studies across all phases of development (Phase 1 to Phase 3), ensuring activities conducted by Contract Research Organizations (CROs) and other partners comply with FDA, EMA, ICH, and other applicable global regulatory requirements, guidelines, and laws.
• Collaborate closely with Clinical Development teams to plan, organize, and prepare clinically focused regulatory documents for submission to regulatory authorities. Offer strategic input on development plans, including trial design, protocols, and essential clinical development documentation
• Develop, implement, and maintain Quality Assurance (QA) programs, policies, and procedures to ensure compliance with applicable GxP standards:
• cGMP for compliance to clinical trial materials
• GLP for compliance to preclinical studies
• GCP for compliance to clinical trials
• Serve as the primary QA liaison with internal teams, external CROs, vendors, contract facilities, and joint development partners, addressing quality issues related to contracts, validation, change management, and other QA-related matters to support key development milestones
• Lead QA reviews of manufacturing records, clinical trial documentation, and documents submitted to regulatory agencies to ensure accuracy, compliance, and readiness
• Oversee and manage the GxP auditing program and all associated inspection activities, including regulatory inspections and internal/external audits.
• Lead the administration of the company’s Standard Operating Procedures (SOP) system and GxP training program to ensure compliance and continuous improvement
• Ensure the company’s electronic systems and document management platforms are compliant with 21 CFR Part 11, overseeing validation and control of document publishing and management systems in collaboration with IT
• Offer strategic leadership and quality oversight of contractor Quality Systems, including change control, deviations, out-of-specification (OOS) results, and CAPA programs
• Evaluate and resolve deviations in a timely manner, ensuring effective implementation of corrective and preventive actions, and escalating issues when appropriate
• Mentor and guide QA team members at all levels, fostering professional development and providing high-level strategic advice to senior management on complex quality and regulatory matters

Professional Qualifications

Minimum Education

BS/BA in a relevant scientific discipline.

Minimum Experience

• Minimum ten (10) years of related experience in a QA function within the pharmaceutical/biotech industry with knowledge of Quality Systems and Quality Assurance processes, development, implementation and documentation.
• Minimum of eight (8) years of working in a GCP QA function
• Two (2) years of experience at a manager level including supervisory experience of QA personnel.
• SME in GCP guidelines, comprehensive knowledge and familiarity with relevant GxP regulations, ICH, and FDA guidelines critical to clinical development.
• Experience in the clinical trials/drug development process and the Federal law and regulations affecting the pharmaceutical industry.

Other Requirements:

Preferred Education

MS/MA or PhD degree in related discipline; an equivalent combination of education and experience may satisfy the preferred qualifications.

Pref. Certification/Licensure:

• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable

Preferred Experience

• Five (5) years of related experience Quality Systems and Quality Assurance processes, development, and documentation.
• Experience in the biotech or pharmaceutical industry in clinical trials/drug development process and the Federal law and regulations affecting the pharmaceutical industry.
• Five (5) years of experience as a QA Manager including supervisory experience of QA personnel.
• Extensive knowledge and familiarity with relevant GxP regulations, ICH, and FDA guidelines critical to clinical development.

Skills: Other

Aptitude: Required/Preferred

Access data in computer data bases

Answer emails/telephones

Compile data/statistics

Coordinate requests, meetings, and events

Coordinate travel arrangements

Establish, organize, and maintain hardcopy and electronic filing systems

Input data into computer programs

Prepare reports

Proofread documents

Schedule appointments

Use computer programs and software packages

Software

MS Office, required

Veeva Quality Docs, Training and or QMS, required

Electronic/cloud-based documentation and filing systems

Machines/Equipment

Personal computer

Computer peripheral equipment

Working / Environmental Conditions

Subject to interruptions

Subject to varying and unpredictable situations

Manages multiple tasks simultaneously

Handle pressure due to multiple calls and inquiries

Handle pressure due to deadline requirements

Requires judgment that could affect image of Fortvita Biologics

Tobacco-free work environment

Physical Demands

Able to travel by car/air (domestic/international) – Est > 20%

Light physical effort

Mostly sedentary work

Occasional standing/walking

Communication

English languages (verbal, written and speaking ability)

Excellent verbal communication and telephone skills

Excellent written communication skills

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Kit Packaging & Visual Inspection Associate

Precision Diagnostics & Radiopharmaceuticals

• Location: Billerica, MA (On-site)
• Shift: 1st Shift (Overtime as required)
• Primary M-F 7-4
• Standard Schedule: Monday through Thursday (four 10-hour shifts).
• Overtime: Overtime is often required on Fridays as needed to meet production goals.
• Environment: Fast-paced, Team-oriented, cGMP Compliant

The Mission: Delivering Excellence Globally

We provide life-saving diagnostic imaging agents to clinicians and patients worldwide. As a member of our Kit Packaging team, you play a vital role in ensuring that every pharmaceutical product is labeled, inspected, and packaged with the highest level of "pharmaceutical elegance" and accuracy before it reaches a patient.

The Role: Your Daily Impact

This is a hands-on, detail-oriented position where you will manage the final stages of the production lifecycle. You will balance manual craftsmanship with automated technology to maintain our world-class quality standards.

Key Responsibilities

• Precision Packaging: Execute the labeling and packaging of pharmaceuticals for worldwide distribution using both manual techniques and automated labeling machinery.
• Visual Quality Inspection: Perform critical visual inspections of filled vials to ensure product integrity and compliance with safety standards.
• Technical Documentation: Accurately follow manufacturing batch records and Departmental SOPs while completing standardized forms with high attention to detail.
• Process Management: Manage area clearances, product accountability, label control, and product segregation to prevent cross-contamination or errors.
• Inventory & Systems: Utilize BPCS/MRP or SAP software to perform inventory transactions, cycle counts, and resolve discrepancies.

What You Bring to the Team

• Compliance Mindset: A strong understanding of cGMP guidelines and a commitment to maintaining a safe, sterile, and organized work environment.
• Adaptability: The ability to pivot quickly to changing production priorities and manage multiple tasks in a high-speed setting.
• Communication: Excellent interpersonal skills with the ability to instruct team members on procedures and participate actively in group problem-solving.
• Technical Literacy: Basic math and science skills relevant to manufacturing, along with a working knowledge of computer-controlled production equipment.

Qualifications

• Education: High School Diploma with 0–3 years of manufacturing experience (Pharmaceutical environment preferred).
• Alternative: An Associate’s Degree with working knowledge of BPCS/MRP and SAP software systems.

Experience:

• Proven success working in team-based environments requiring extreme accuracy and self-motivation.

Technical Writer – Newtown, PA

The Technical Writer will support oral solid dosage pharmaceutical manufacturing by authoring, revising, and maintaining high-quality technical documentation in compliance with cGMP and FDA requirements. This role partners closely with Technical Services, Manufacturing, Quality Assurance, Validation, and Engineering to ensure controlled documents are accurate, clear, consistent, and inspection ready. The ideal candidate will demonstrate strong technical writing skills, attention to detail, and experience working within a regulated pharmaceutical manufacturing environment.

• This position’s responsibilities will include, but not be limited to the following:Author, review, and maintain controlled technical documents, including Standard Operating Procedures (SOPs), Master Production Records (MPRs), Master Packaging Records (MPKs), protocols, and technical reports.
• Prepare and revise documentation associated with technical changes, including change controls, risk assessments, and supporting justifications, in collaboration with cross-functional stakeholders.
• Support deviation, investigation, and CAPA documentation by drafting clear, factual, and technically accurate narratives and supporting documentation.
• Collaborate with subject matter experts across Technical Services, Manufacturing, Quality Assurance, Validation, and Engineering to translate complex processes into clear, compliant documentation.
• Ensure all technical documentation complies with cGMP requirements, FDA regulations, and internal document control standards.
• Participate in document lifecycle activities, including periodic review, version control, and archival, to maintain accuracy, consistency, and inspection readiness.
• We are looking for applicants with:Bachelor’s degree from an accredited college or university in a scientific, technical, or related discipline (e.g., Chemistry, Pharmaceutical Sciences, Biology, Engineering, or Technical Communication) required.
• Minimum of 1–5 years of experience authoring and managing technical documentation within a regulated pharmaceutical manufacturing environment.
• Experience supporting oral solid dosage manufacturing documentation strongly preferred.
• Solid understanding of cGMP principles and regulated documentation practices.
• Strong technical writing skills, including grammar, structure, clarity, and attention to detail.
• Ability to interpret technical information and collaborate effectively with subject matter experts.
• Proficiency with standard office software and document management systems used in regulated environments.
• Strong organizational skills and ability to manage multiple documents, priorities, and deadlines.
• Effective written and verbal communication skills and willingness to learn manufacturing processes and regulatory expectations.

Position Summary:

We are seeking a detail-oriented and motivated Junior Accountant to join our Finance team,

with a specialized focus on pharmaceutical accounting. This role is ideal for someone with

foundational accounting experience and a strong understanding of the pharmaceutical

industry’s understanding of G2N and revenue analysis, rebate structures, including

commercial, Medicaid, and Medicare Part D programs.

Key Responsibilities:

• Assist in the preparation, review, and processing of rebate claims and accruals.
• Support monthly, quarterly, and annual financial close activities related to rebates.
• Reconcile rebate-related accounts and ensure accuracy of general ledger entires.
• Collaborate with cross-functional teams including Sales, Contracts, and Market Access to validate rebate data.
• Maintain documentation and audit trails for all rebate transactions
• Assist in preparing reorts and analysis for management and external auditors
• Ensure compliance with GAAP and internal financial policies
• Participate in system upgrades or implementations related to rebate tracking and accounting
• Perform other duties as assigned

Qualifications

• Degree in Accounting, Finance, or related field
• 1-3 years of accounting experience, preferably in the pharmaceutical or halthcare industry
• Familiarity with rebate programs (e.g., Commercial, Medicaid, Medicare Part D)
• Strong Excel Skills; experience with ERP systems (e.g., QuickBooks, SAP) is a plus
• Excellent attention to detail and organizational skills
• Ability to work independently and as part of a team in a fast-paced environment

Preferred Skills

• Experience with contract management systems and rebate processing platforms
• Understanding of government pricing regulations and pharmaceutical compliance
• Strong analytical and problem-solving abilities

To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.

The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Luye Pharma is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Location: Mercy Northwest Arkansas

The Manager–Specialty Pharmacy is responsible for the coordination, oversight, and implementation of Specialty Pharmacy Services at the assigned location. This leader ensures full compliance with local, state, and federal regulations across Mercy Pharmacy Services (MPS) Company 80 sites. The role is responsible for identifying potential or existing drug‑related issues, taking proactive action to prevent or resolve them, and partnering closely with medical staff to develop and implement pharmaceutical protocols. This position also supports the development and ongoing management of specialty pharmacy systems and workflows.

• Maintain strict confidentiality of patient, visitor, and coworker information and comply with all HIPAA Privacy Rule standards.
• Adhere to Mercy and departmental policies related to risk management, safety, medication use, security, fire safety, and infection control.
• Ensure compliance with all federal, state, and local laws, rules, and regulations.
• Use internal and external data to continuously improve pharmacy operations.

• Direct the development, implementation, and ongoing management of specialty pharmacy services; monitor program performance and report to pharmacy leadership.
• Lead initiatives involving technology, staffing models, scheduling, and formulary management that enhance pharmacy service levels.
• Develop and implement targeted pharmacy operational practices that improve patient care, safety, and cost‑effectiveness.
• Coordinate identification, resolution, and communication of pharmacy operational issues with other departments.
• Provide Medication Therapy Services, including patient assessment and clinical recommendations regarding medication selection, dosing, scheduling, contraindications, and interactions.
• Collaborate with medical staff to clarify orders and optimize drug therapy.
• Develop and update policies, procedures, and training materials for pharmacy programs and pharmaceutical care.
• Coordinate 340B pharmacy programs at eligible sites.
• Align specialty pharmacy services with Ministry‑wide initiatives.
• Provide accurate drug information to physicians, pharmacists, nurses, and other healthcare professionals.
• Ensure compliance with REMS programs and Limited Distribution Drug (LDD) requirements, including enrollment, renewals, training, and reporting.
• Ensure all coworkers are trained on REMS/LDD risks, monitoring, dispensing, and documentation requirements.

• Participate in the orientation and training of pharmacists, technicians, residents, students, and technical support staff.
• Develop and present educational materials to enhance pharmacy coworkers’ knowledge and skills.
• Respond to complex pharmacy operations inquiries.
• Maintain professional competence through ongoing development and involvement in activities that advance pharmacy practice.
• Monitor pharmacy operational performance through monthly review of financial statements.

• Participate in quality improvement and patient safety initiatives, especially those related to medications and pharmacy operations.
• Review and verify the work of pharmacy coworkers to ensure accuracy, compliance, and completeness.
• Ensure compliance with Board of Pharmacy requirements and other accrediting or regulatory agencies.
• Demonstrate understanding of patient and workplace safety principles by preventing errors, reporting concerns, and supporting safe practices.
• Maintain knowledge of DME POS, HIPAA, OSHA, and other regulations guiding pharmacy and healthcare operations.
• Track and audit compliance with all applicable jurisdictional laws and regulations.
• Respond to detected risks, incidents, or compliance concerns and take corrective action to prevent recurrence.

• Delegate appropriately and hold coworkers accountable to policies, standards, and expectations.
• Promote a positive, healthy work environment that supports clinical excellence and strong training practices.
• Participate in hiring, performance management, evaluations, and staff development.
• Develop and maintain policies and procedures that support pharmacy operations.
• Give and receive constructive feedback in a timely manner.
• Serve as a role model and mentor to pharmacy staff.
• Participate in departmental and regional budgeting processes.
• Perform other duties as assigned.

Education:

• Bachelor of Science in Pharmacy and/or Doctor of Pharmacy (PharmD)

Licensure:

• Eligible for or possess current applicable state Pharmacist licensure(s)

Experience:

• Minimum of 3 years of experience in an ambulatory or retail pharmacy setting
• Minimum of 3 years of management experience

Certification:

• State Board of Pharmacy Medication Therapy Services Certificate (where applicable)

Skills & Competencies:

• Strong clinical knowledge across all age groups served
• Effective communication and interpersonal skills
• Ability to demonstrate empathy, warmth, and professionalism
• Strong investigative, analytical, and problem‑solving skills
• Excellent judgment, attention to detail, and follow‑through
• Ability to manage stress, adapt to change, and maintain awareness of how decisions affect others

From day one, Mercy offers outstanding benefits - including medical, dental, and vision coverage, paid time off, tuition support, and matched retirement plans for team members working 32+ hours per pay period.

Join a caring, collaborative team where your voice matters. At Mercy, you'll help shape the future of healthcare through innovation, technology, and compassion. As we grow, you'll grow with us.