Keysource Pharmaceuticals Jobs in Usa
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This role serves as a technical and operational resource on the production floor, supporting production flow, compliance, and continuous improvement without formal supervisory authority.
Job Description AVAILABLE SHIFTS: 1st Shift: Mon-Fri 6am-2:30pm 2nd Shift: Mon-Fri 2pm-10:30pm 3rd Shift: Mon-Fri 10pm-6:30am MAJOR RESPONSIBILITIES Acts as a technical and workflow lead by coordinating daily manufacturing tasks, prioritizing activities, and supporting efficient production flow without formal people management responsibility.
Provides on-the-job guidance, mentoring, and training to manufacturing technicians and lower-level operators to ensure adherence to procedures, safety standards, and GMP requirements.
Performs advanced, hands-on biopharmaceutical manufacturing activities, including media and buffer preparation, aseptic processing, equipment cleaning and sterilization, and any responsibilities to support production and schedule adherence.
Sets up, operates, monitors, and adjusts bioprocessing equipment such as autoclaves, washer-sterilizers, filtration systems, fermenters, and fill-finish equipment.
Prepares, cleans, assembles, and stages tanks, glassware, components, and systems for batch manufacturing operations in accordance with approved procedures.
Monitors critical process parameters, production data, and outputs to ensure compliance with batch records, specifications, and quality standards.
Identifies, documents, and escalates deviations, abnormal events, and process issues in accordance with quality systems and regulatory expectations.
Maintains accurate and complete batch documentation, equipment logs, inventory records, and other GMP compliance documentation.
Follows and reinforces standard operating procedures (SOPs), manufacturing instructions, and all applicable safety, quality, and regulatory guidelines.
Collaborates with engineering, quality, and maintenance teams on troubleshooting, investigations, testing, and process optimization activities.
Supports continuous improvement initiatives by providing technical input, identifying opportunities for efficiency or quality improvements, and assisting with implementation of approved changes.
MINIMUM JOB REQUIREMENTS Education High school diploma or GED required Work Experience 2-3 years of manufacturing experience.
Experience in aseptic manufacturing experience in GMP and ISO-cleanroom environments.
Knowledge / Skills / Abilities Proven ability to operate, monitor, troubleshoot, and maintain biopharmaceutical manufacturing equipment.
Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.
Effective communication and interpersonal skills, including the ability to guide and collaborate with others.
Comfortable working in cleanroom and controlled environments while adhering to gowning, safety, and quality requirements.
Flexibility to work mandatory overtime based on business needs.
Ability to speak, read, and write English with proficiency PREFERRED JOB REQUIREMENTS Education Bachelor's degree in STEM field Work Experience 2 years of hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing.
Demonstrated experience performing advanced manufacturing operations such as aseptic processing, media/buffer preparation, and equipment operation Knowledge / Skills / Abilities Advanced knowledge of upstream and/or downstream bioprocessing operations Experience supporting audits, inspections, and regulatory interactions Familiarity with continuous improvement methodologies and operational excellence initiatives Strong problem-solving skills with the ability to work cross-functionally Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $28.75
- $41.75 Hourly The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Responsibilities: Follow Master Batch Records for the manufacturing of controlled, oral solid dose (OSD) and other dosage forms when required.
Prepare raw materials, blends, and bulk accountability throughout manufacturing processes.
Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures.
Operate scales including set-up, verification, leveling, and challenging.
Identify, report, and resolve quality issues.
Set up, operate, and clean manufacturing equipment safely and in compliance with batch records and SOPs.
Perform in-process testing and inspections as required by Master Batch Record.
Clean and sanitize manufacturing rooms including walls, floors, and ceilings per SOPs.
Report accidents and unsafe conditions or unusual circumstances to supervisor.
Complete accurate and timely documentation following good documentation practices in accordance with GMP.
Actively participate in Production team and Site communication meetings.
Maintain regular and punctual attendance; work overtime as required.
Support GMP investigations and events.
Identify and report potential GMP impacting situations.
Contribute to Standard Operating Procedure (SOP) writing in your technical area.
Requirements: High School Diploma or equivalent.
Up to three years pharmaceutical industry experience preferred or an equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry.
Required Skills: General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division.
Understanding of the Metric System of Measurement.
Strong attention to detail and ability to write and record data legibly and accurately in accordance with cGMP regulations.
Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.
Preferred Skills: Experience in oral solid dose (OSD) pharmaceutical manufacturing Granulation/Blending and Bead Coating operations.
Benefits: Wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator).
Occasionally, transport materials using manual and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets.
Lift and maneuver empty drums weighing up to 40 pounds up to five times per day; push and maneuver drums containing product weighing up to 275 pounds up to five times per day.
Perform cleaning and assembly/disassembly on production equipment which may require pulling, pushing, or twisting to remove equipment shields, parts, and panels.
Management Sciences for Health (MSH) is a global health nonprofit that makes foundational changes to health systems to protect people from diseases and improve their health. MSH collaborates with local partners, from the Ministry of Health to the community, to strengthen and complement existing health systems. Since 1971, MSH has worked in more than 150 countries to help ensure sustainable, resilient, and equitable access to quality health care around the globe.
MSH invites qualified, individual consultants to express their interest in joining the MSH Consultant Roster for potential future collaborations in the global health sector. We encourage professionals with diverse skills and experiences to express their interest in joining the roster by submitting an application.
Consultants can be remote or on-site as required by MSH.
Instructions for ApplyingFill out the online application form and attach your latest CV and a cover letter. Applicants must indicate their skills by selecting them from the drop-down list. Please note that submission of an application does not guarantee automatic selection for the roster. MSH will contact candidates as needed.
QualificationsRequired Skills: Applicants that wish to apply for the Supply Chain & Pharmaceutical System Strengthening roster should possess the following skills/experiences:
- Supply Chain Management
- Pharmaceutical System Strengthening
- Supply Chain Planning
- Supply Chain Systems
- Logistics Management Information Systems
- Track and Trace
- CO2 Emission Reduction
- Stakeholder Management & Governance
- Performance & Reporting
MSH 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, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. MSH complies with Section 503 of the Rehabilitation Act, Section 4212 of the Vietnam Era Readjustment Assistance Act, as amended, and all related applicable regulations.
Operators serve on the front line of aseptic behavior, environmental discipline, and product integrity, supporting compliant and efficient manufacturing operations.
Job Description AVAILABLE SHIFTS: 1st Shift: Mon-Fri 6am-2:30pm 2nd Shift: Mon-Fri 2pm-10:30pm 3rd Shift: Mon-Fri 10pm-6:30am MAJOR RESPONSIBILITIES Cleanroom Conduct & Gowning Follow all cleanroom gowning requirements and adhere to gowning and material entry‑ protocols.
Follow good aseptic practices when performing all tasks within ISO-certified environments.
Pre-Run Preparation Complete all pre-run checks, including: Reconciliation of materials.
Verifying process piping cleaning requirements for the upcoming batch.
Confirming availability of cloth rolls, film, solution, and other materials.
Material Staging Stage cloth rolls, film, and other packaging materials per established procedures to minimize contamination risk.
Maintain unidirectional flow of cloth, film, totes, and packaging components to prevent cross contamination.
Manage raw materials to ensure expired or incorrect lots are not used.
CIP/COP Processes Perform all cleaning activities related to process piping and components according to established procedures.
Execute sanitization cleaning cycles for all raw materials entering cleanroom environments.
Perform sanitization steps for all tools/equipment and execute proper changeover cleaning sequences.
Documentation & Escalation Real-time, accurate, and complete documentation on all forms and records.
Follows Good Documentation Practices Immediately escalate deviations to the Supervisor or Quality.
Cleaning & Responsibilities Perform cleaning activities according to established procedures.
Handle scrap per established procedure and ensure dedicated scrap receptacles never leave the cleanroom.
Safety & Ergonomics Follow all EHS procedures, including chemical handling requirements.
Use proper ergonomic techniques when lifting and moving materials.
MINIMUM JOB REQUIREMENTS Education High school diploma or GED required Work Experience Prior manufacturing experience.
Knowledge / Skills / Abilities Must be able to lift up to 50 lbs.
Must be able to bend, twist, reach, push, lift for extended periods daily.
Comfortable working in cleanroom and controlled environments while adhering to gowning, safety, and quality requirements.
Other duties as assigned.
Flexibility to work mandatory overtime based on business needs.
Ability to speak, read, and write English with proficiency PREFERRED JOB REQUIREMENTS Work Experience Experience in aseptic manufacturing experience in GMP and ISO-cleanroom environments.
Knowledge / Skills / Abilities Strong working knowledge of GMP regulations, aseptic techniques, and biopharmaceutical manufacturing processes, with the ability to execute work in compliance with SOPs, batch records, and technical documentation.
Proven ability to operate, monitor, troubleshoot, and maintain biopharmaceutical manufacturing equipment.
Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.
Effective communication and interpersonal skills, including the ability to guide and collaborate with others.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $20.25
- $29.25 Hourly The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Title: Data Migration Specialist
Location: San Diego, CA
Duration: 6-9 Month Assignment + Potential Extensions
Work Model: Fully On-Site
Pay rate: $21-23/hour
Start Date: March 16, 2026
JOB DESCRIPTION
One of our large CDMO clients is seeking data migration specialist to transition from a legacy Quality Management System (QMS) to MasterControl. This role focuses on extracting structured and unstructured data from the previous QMS platform, validating its accuracy, and entering and organizing information within MasterControl according to established procedures. The ideal candidate is detail‑oriented, highly organized, and comfortable working with quality documentation and regulated data environments.
Key Responsibilities
- Extract data from the legacy QMS, including documents, records, metadata, and historical logs.
- Review, clean, and validate extracted data to ensure accuracy, completeness, and compliance with internal standards.
- Input and upload data into MasterControl following defined workflows and naming conventions.
- Collaborate with Quality, IT, and Compliance teams to resolve discrepancies and clarify data requirements.
- Maintain detailed logs and status reports to track progress and identify issues during migration.
- Support testing and verification activities to ensure data integrity after import into MasterControl.
- Follow all SOPs, work instructions, and regulatory guidelines related to data handling and documentation control.
Required Skills and Experience:
- High School Diploma
- Experience with Data Entry or Document Control in a regulated environment
- Ability to type 40+ words per minute
- Microsoft Office proficiency
Nice to Have Skills & Experience:
- Experience with MasterControl
Compensation:
$21.00/hr to $23.00/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k)-retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.
Senior Analyst, Sales Operations, Basking Ridge, NJ
Who We Are
Aucta Pharmaceuticals is an emerging product development pharmaceutical company.We are on our way to becoming a significant specialty pharmaceutical company in the U.S. marketplace integrating R&D, manufacturing, and commercialization. We focus on improved dosage forms for patients with a therapeutic focus in CNS and select orphan drug disease states.
Aucta successfully launched its first branded product, Motpoly XR, in the epilepsy space with a targeted sales force in March 2024 and an expanded presence of 20 field sale territories and 3 inside sales positions in late 2024. Our objective is to enhance our marketing, managed care, and sales capabilities to support future pipeline products in neurology over the coming years.
Position Description
The Senior Analyst, Sales Operations, is a key member of Aucta’s Commercial Operations team and plays a critical role in enabling sales effectiveness, operational execution, and data-driven decision-making across the organization.
This role serves as the primary point of contact and vendor manager for core Sales Operations platforms, including Veeva CRM, MMIT, and Power BI, and is responsible for managing core quarterly commercial processes such as Incentive Compensation updates, targeting changes, sales force size and structure adjustments, and system governance.
In addition, this position leads the development and maintenance of training materials and delivers training for both field and inside sales and home office teams across Commercial Operations tools and platforms.
This is a highly visible, hands-on role in a fast-growing environment that requires strong analytical skills, operational rigor, comfort working cross-functionally, and the ability to translate complex data and systems into clear, actionable guidance for the business.
The role reports to the Director of Sales Operations.
Primary Responsibilities:
Sales Operations & Vendor Management
- Serve as the primary point of contact and internal owner for Sales Operations tools and vendors, including Veeva CRM, MMIT, Power BI, and related commercial analytics platforms.
- Manage vendor relationships, system enhancements, issue resolution, upgrades, and roadmap discussions to ensure tools meet evolving business needs.
- Partner with IT, Finance, Sales leadership, and external vendors to maintain data integrity, system performance, and compliance.
Commercial Process Management
- Own and manage the quarterly change process for:
- Incentive compensation plan updates and calculations
- Targeting and call plan changes
- Sales force size, structure, and territory adjustments
- Ensure timely, accurate execution of all changes and clear communication with stakeholders.
- Support forecasting, goal setting, and sales performance tracking activities.
Analytics & Reporting
- Utilize advanced Excel, SQL, and Power BI to analyze sales performance, trends, and operational KPIs.
- Build, maintain, and enhance dashboards and reports to support Sales leadership, Commercial Operations, and Executive leadership.
- Partner cross-functionally to translate business questions into data-driven insights.
Training & Enablement
- Develop, maintain, and continuously improve training materials (guides, SOPs, slide decks, job aids) for Sales Operations tools and processes.
- Conduct training sessions for field and inside Sales and home office associates on:
- Veeva CRM functionality and best practices
- MMIT data usage and interpretation
- Power BI dashboards and reporting
- Other Commercial Operations platforms as needed
- Serve as a trusted resource for ongoing user support and best-practice guidance.
Cross-Functional Support
- Collaborate closely with Sales, Marketing, Managed Care, Finance, and leadership to support commercial execution.
- Participate in sales meetings, planning sessions, and plan-of-action meetings as needed.
- Identify opportunities for process improvement, automation, and scalability as the organization grows.
Required Qualifications
- Bachelor’s degree in Business Administration, Finance, Analytics, Information Systems, or a related field.
- 3-5+ years of experience in Sales Operations, Commercial Operations, or analytics roles, preferably within the pharmaceutical or healthcare industry.
- Hands-on experience with Veeva CRM, MMIT, and Power BI strongly preferred.
- Advanced proficiency in Microsoft Excel (including complex formulas and data modeling); SQL experience preferred.
- Strong understanding of sales force structure, targeting, incentive compensation, and CRM processes.
- Demonstrated ability to manage vendors and cross-functional stakeholders.
- Strong communication and training skills, with the ability to explain technical concepts to non-technical audiences.
- Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
- Proactive, collaborative team player with a strong sense of ownership and accountability.
Work Location:
This position is based at our Basking Ridge, NJ site. It is an office-based role, requiring presence 5 days a week. The selected candidate must be able to commute to Basking Ridge, NJ
Salary Range
Aucta Pharmaceuticals considers a combination of education, experience, internal equity, and external market data when determining compensation.
- Base Salary: $80,000 – $110,000 (commensurate with experience)
- Bonus Incentive: 10%
Benefits
Aucta offers a competitive benefits package, including:
- Medical, Dental, and Vision Insurance
- 401(k)
- Life Insurance
- Short- and Long-Term Disability
- Paid Time Off (PTO)
Aucta Pharmaceuticals is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Please refrain from forwarding unsolicited resumes from agencies to Aucta Pharmaceuticals. Aucta is not liable for any fees incurred from the use of resumes from this source. We only compensate agencies with whom we have a formal agreement. For recruitment inquiries, please reach out directly through this post
Applications will be accepted until the position is filled.
Prinston Pharmaceutical Inc.
About Us:
Prinston Pharmaceutical, Inc. is a fully integrated pharmaceutical company engaged in product development, product registration, manufacturing, marketing, and sales of high-quality affordable generic prescription products to customers. We deliver and maintain high quality and integrity in all our products manufactured in world-class cGMP manufacturing facilities. Our highly experienced R&D team meets market needs through innovation rapidly, bringing cost-effective quality products to the US market and help patients get the best pharmaceutical products simultaneously reducing their medical cost. We currently have an immediate opening for a corporate paralegal at Prinston Pharmaceuticals Inc., located in Somerset, New Jersey. This is an excellent opportunity to work on meaningful projects and exposure to a corporate environment in global/international setting.
Job Title: Paralegal
Corporate Paralegal/Legal Assistant will work on a range of projects that will support the legal team.
Roles and Responsibilities:
Assist with reviewing, drafting and revising various contracts to support sales and marketing teams including CDAs, MSAs, SOWs, supply agreements, collaboration agreements, etc.
- Prepare correspondence, reports, presentations, and other materials.
- Perform legal research.
- Review and monitor laws and regulations in relevant fields.
- Maintain procedures, forms, and legal policy documents.
- Assist with litigation and dispute resolution.
- Manage Intellectual property portfolios.
- Coordinate matters with Human Resources, as necessary.
- Other duties may be assigned.
Qualifications:
- B.A with prior legal assistant/paralegal experience or currently enrolled in a J.D. program at an accredit academic institution, preferably second or third-year law student.
- Extensive knowledge of corporate governance, intellectual property, employment litigation and Human Resources related law is required.
- A corporate paralegal with prior experience at a pharmaceutical manufacturer.
- Strong organizational, customer service, and project management skills.
- Strong work ethic, positive attitude, and professional demeanor.
- Ability to work independently and as part of a team.
- Excellent verbal and written communication skills.
- Must be eligible to work in the U.S. and able to start work immediately
Benefits:
- 401(k)
- Health insurance
- Dental insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Job Type: Full-time
Salary: $70,000 - $90,000
Location: Somerset, NJ (on-site)
Job Overview:
Armas Pharmaceuticals is seeking a highly analytical and detail-oriented Business Data Analyst to join our growing team. This entry-level position is ideal for a recent graduate who is passionate about data analysis, business intelligence, and process improvement.
The analyst will play a key role in supporting the Finance and Operations teams by analyzing business data, preparing reporting for senior leadership, and helping improve internal data systems. The role requires strong Excel proficiency, analytical thinking, and the ability to translate raw data into actionable insights.
This position offers a unique opportunity to work cross-functionally while contributing to strategic decision-making and operational efficiency.
Key Responsibilities:
Data Analysis & Reporting
• Analyze business and sales data to identify trends, patterns, and performance insights.
• Prepare structured data sets and reports for senior management and leadership review.
• Support ongoing business reporting initiatives through data analysis and visualization.
Financial & Operational Support
• Assist the finance team with data preparation, analysis, and reporting processes.
• Support financial modeling and reporting through structured data organization.
• Ensure accuracy and consistency of financial and operational datasets.
Data Systems & Automation
• Assist in developing and improving automated reporting processes using Excel and related tools.
• Contribute to the expansion and maintenance of the company’s internal data warehouse.
• Identify opportunities to streamline workflows through automation and improved data structures.
Partner & Business Intelligence Support
• Prepare partner data and operational metrics to support leadership reporting.
• Work with cross-functional teams to compile and analyze key business metrics.
• Help develop scalable data processes that improve business visibility.
Innovation & Technology
• Explore opportunities to leverage AI tools and integrations to enhance business intelligence, automation, and reporting capabilities.
• Assist in identifying technologies that improve data accessibility and decision-making.
Qualifications:
Education
• Bachelor’s degree required in one of the following or related fields:
· Finance
· Economics
· Business Analytics
· Data Science
· Mathematics
· Information Systems
· Business Administration
Required Skills
• Advanced Microsoft Excel skills (pivot tables, advanced formulas, data analysis tools).
• Strong analytical and critical thinking ability.
• Ability to organize and interpret large datasets.
• Excellent attention to detail and data accuracy.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating across departments.
Preferred Skills (Bonus)
• Experience with data visualization tools (Power BI, Tableau, etc.)
• Exposure to SQL or database systems
• Familiarity with data warehouse concepts
• Experience integrating or applying AI tools to business processes
Compensation & Benefits:
• Salary: $50,000 – $60,000 annually
• Performance-based bonus opportunity
• Full-time employee benefits including:
• Health insurance (after eligibility period)
• 401(k) retirement plan (after eligibility period)
• Paid Time Off (PTO)
• Participation in company incentive programs
About Armas Pharmaceuticals, Inc.
Armas Pharmaceuticals is a generic pharmaceutical company delivering an ever-growing portfolio of high-quality products that provide convenience, affordability, and consistency. Through the development of strong partnerships and industry relationships, Armas maintains this pipeline of products with customer and patient satisfaction in mind. Headquartered in Freehold, New Jersey, Armas Pharmaceuticals is always open to new partnership opportunities and ways to offer our customers the best products at affordable prices. For more information, please visit .
Work Shift
The Pharmacy Residency Prgogram has an exciting opportunity for a Pharmacy Resident (PGY1)!
Job Summary:
The major responsibilities of this position are drug distribution, clinical intervention, education, administration, drug information and research.
Core Responsibilities and Essential Functions:
Clinical Intervention
* a. Maintains competency in all aspects of drug therapy for patients of all age groups.
* b. Provides pharmaceutical care by assisting other health care providers or providing direct patient care by:
* Assessing patient demographics
* Reviewing patient medication history
* Developing pharmacotherapeutic plans
* Developing drug monitoring plans
* Implementing new drug regimens
* Documenting medication related issues
* Interpreting laboratory data
* Reviewing patient medication profiles and making recommendations for drug therapy management
* Makes patient care rounds focusing on drug therapy issues
* Monitors drug therapy to evaluate appropriateness of use, dose, dosage form, regimen, route, therapeutic duplication, and drug interactions
* c. Provides pharmacokinetics consultations as required, specifically addressing drugs with narrow therapeutic indices.
* d. Participates in drug therapy management during codes.
* e. Maintains and updates a patient profile with demographics, diagnosis, allergies, and current medications.
* f. Discusses medication order clarifications with the prescriber, document changes in patient and pharmacy records.
* g. Reconciles pharmacy and nursing medication records daily.
* h. Provides on-call coverage for pharmaceutical care as requested.
* i. Identifies and proceeds with cost avoidance in drug therapy by promoting more cost effective regimens, drugs, and by reducing waste.
Drug Distribution
* a. Residents provide the equivalent of approximately 20 hours per month (excluding orientation and transition rotation) of pharmacy practice staffing during the residency program.
* b. Promotes use of WHS formulary by converting non-formulary orders to formulary when possible.
* c. Resident is scheduled to work their required shifts primarily in the Central Pharmacy or Resource Zone to gain a working knowledge of hospital pharmacy operations.
* Checks unit dose medications for accuracy
* Reviews and verifies medication orders for appropriateness and checks first doses of IV admixtures and unit dose medications prepared by technicians
* Ensures proper technique and accurate preparation of all pharmaceutical products, including oral, IV admixtures, chemotherapeutic, and investigational agents
* Ensures the timely and accurate dispensing of drugs and solutions from the pharmacy area
* Responsible for the accurate filling and dispensing of medication orders used by inpatients
* Provides drug information to health care professionals and to patients
* Reviews physician orders for possible therapeutic problems, contraindications, interactions, allergies, and formulary status of the drug
* Provides computer order entry for IVs and other computer entry as needed
* Ensures compliance with controlled substance distribution and maintenance system
* Is able to practice in a variety of areas within the pharmacy as required by workload
Education
* a. Precepts Pharm.D. clerkship students consistent with academic credentials and clinical experience.
* b. Provides presentations, publications, and other informative activities on drug-related topics to the health care community and general public.
* c. Participates in continuing education programs, meetings, training programs and related activities.
* d. Educates patients on admission or discharge medications as necessary or requested.
Drug Information and Research
* a. Participate as a member of WHS Pharmacy and Therapeutics (P&T) Committee.
* b. Monitoring patient outcomes in relation to medication use. Conducts target drug programs and medication use evaluations as needed.
* c. Detects, prevents, monitors, documents, and reports ADEs and MEs.
* d. Provides drug information to health care professionals and to patients.
* e. Assist in formulary maintenance by critiquing new entities, comparing medication classes, and developing therapeutic interchanges, when applicable.
* f. Assist in developing drug clinical practice guidelines (CPGs) as needed.
* g. Complete a research project designed to improve the services of the department
Administration/leadership
* a. Documents clinical interventions (pharmacokinetic consultations pharmacotherapeutic consultations, anticoagulation consultations, patient consultations) and cost avoidance as part of the Pharmacy Services and hospital documentation programs.
* b. Assist in preparing for and maintaining compliance with regulatory agency (e.g. The JC) standards/requirements.
* c. Participate on committees, teams, or task forces relating to area of preceptors individual practice.
* d. Meet with pharmaceutical sales representatives to obtain/assess clinical data.
* e. Attend Directors meetings (e.g. Pharmacy Directors, Partners).
* f. Assist with coordinating clinical pharmacy activities, schedules, programs and projects.
* Performs other duties as assigned
* Complies with all WellStar Health System policies, standards of work, and code of conduct.
Required Minimum Education:
- High School Diploma General or GED General
- Enrolled or Completion of an accredited college of Pharmacy.
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
- RPH - Registered Pharmacist or RPH-P - Reg Pharmacist Provisional (180 Days) within 180 Days.
Additional License(s) and Certification(s):
- Licensed by or eligible for licensure with the Georgia State Board of Pharmacy upon hire.
- If not licensed at the start of residency, the candidate must be licensed by August 31st of their residency year.
Required Minimum Skills:
- Strong verbal and written communication skills.
- Computer Skills: Microsoft Office suite including Word and PowerPoint.
- Strong organizational skills.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Primus Pharmaceuticals is seeking a versatile Clinical Research Associate (CRA) to support the conduct of prescription medical foods clinical trials at a growing pharmaceutical company. This role offers a mix of remote monitoring, site activities, and in-office collaboration at our Scottsdale headquarters. This role is ideal for a professional who enjoys both hands-on site engagement and strategic oversight responsibilities in a fast-paced environment.
Primus is an innovative company with novel products based on unmet needs that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. We are scaling proven brands into their next chapter, and the ideal candidate will find this motivating and have the leadership and skills to drive results.
Position Overview
The CRA will collaborate closely with Primus, the vendors, and investigative sites to ensure high-quality, compliant study execution. This role requires effective communication, and the fostering of strong site relationships and operational excellence.
Roles & Responsibilities
Vendor & Site Oversight
- Provide operational oversight of monitoring activities, including the development of monitoring visit reports, follow-up letters, and issues escalation.
- Track site and vendor performance against key deliverables, KPIs, and study timelines.
- Review Trial Master File (TMF) content for accuracy and completeness.
- Contribute to study-specific documents, including monitoring, communication, and risk management plans.
In-Field & Site Monitoring
- Conduct qualification, initiation, interim monitoring, and close-out visits at investigational sites as needed.
- Verify informed consent documentation, source data, case report forms (CRFs), investigational product accountability, and protocol compliance.
- Identify and resolve protocol deviations, compliance issues, and data discrepancies directly with site personnel.
- Serve as the primary point of contact for assigned sites, building strong relationships with investigators and staff.
- Provide ongoing training and support to sites on protocol requirements, study tools, and GCP compliance.
Cross-Functional Support
- Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) to ensure aligned trial execution.
- Support the design, development, and refinement of essential clinical trial documents, including Case Report Forms (CRFs), monitoring plans, and study-specific instructional manuals.
- Support audit/inspection of readiness and contribute to corrective/preventive action (CAPA) planning.
- Assist in site and vendor governance meetings by providing operational feedback and insights.
Qualifications
Education & Experience
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field. (Requirement may be waived for candidates with 5+ years of directly relevant professional experience) .
- 3–6 years of clinical research experience, including at least 2 years as a CRA.
- Experience in both site/vendor oversight and direct site monitoring (pharma, biotech or CRO background preferred).
Technical Skills
- EDC Proficiency: Strong technical experience using Electronic Data Capture (EDC) platforms for data entry, query management, and source data verification (SDV).
- Platform Knowledge: Familiarity with industry-standard platforms such as Medidata Rave, Veeva Vault EDC, JotForm or Medrio.
- Compliance: Deep knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, and standard clinical trial processes.
General Skills
- Demonstrated ability to manage multiple sites/trials across various therapeutic areas.
- Excellent communication, organizational, and problem-solving skills.
- Willingness to travel (approximately 10–20%).
- Comfortable working in a smaller pharmaceutical setting with the flexibility to take on broad responsibilities.
About Primus Pharmaceuticals, Inc.
Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women’s health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at
