Keysource Pharmaceuticals Jobs in Usa

On-Site Quality Engineer in Albany, NY

ADVENT Engineering, a Trinity Consultants Company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered in Dallas, TX with operations in the Eastern US and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of Compliance Specialists involved in the creation, tracking, and closure of CAPAs associated with facilities maintenance. Forming and working within cross functional teams is considered an asset.

A combination of strong technical aptitude, preventative maintenance experience, and data analysis are the desired skill set.

This is an outstanding opportunity to join our growing team!

Qualifications:

Bachelor’s Degree/Undergraduate degree in Engineering, Biology, or equivalent. At least 5 years of related work experience in a QA or Compliance setting.

Requirements:

• Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to implement Corrective and Preventative Actions
• Manages and participates in Facilities Department CAPA Program. Ensures that all activities related to CAPAs are performed in a timely manner and in compliance with procedures and regulatory requirements.
• Daily monitoring and tracking of CAPAs assigned to the facilities department.
• Responsible for all aspects of CAPA ownership including facilitation of cross functional meetings with relevant stakeholders, completion of extension requests where applicable, and submission of evidence to QA.
• Initiation and ownership of requests and workflows in Computerized Maintenance Management System (BMRAM)
• Attend Weekly Meetings to discuss CAPA progress and escalation of obstacles, including presenting, taking notes, managing agenda items and invites.
• Ownership of CAPA Effectiveness Checks including the review and analyzing of relevant data and completing reports documenting findings
• Provides support and training for Facilities personnel on regulatory and quality topics, such as proper documentation procedures and the use of QUMAS.

Key responsibilities:

• Well-developed communication skills, both verbal and written.
• Outstanding Organization skills (required to handle multiple projects concurrently)
• Strong data analysis skills (excel, performance metrics).
• Strong GMP background including working knowledge of preventative maintenance principles.
• Familiar with a broad range of equipment used in pharmaceutical production, including but not limited to: bioreactors, chromatography skids, centrifuges/separators, air handlers, HEPA.

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

A Product Surveillance Specialist is primarily responsible for monitoring the safety, quality and efficacy of products marketed and sold by Par Health (“The Company”). This is accomplished by receiving, capturing and evaluating product feedback reports from the field in accordance with current FDA and global regulations and guidelines. Additionally, they provide technical and clinical information regarding product usage and performance. As a result of these activities, they will frequently develop, preserve and strengthen customer relationships which is a necessary and expected commodity in today's competitive pharmaceutical, biologic and medical device industries. Establish and maintain positive and mutually rewarding relationships with internal customers.

ESSENTIAL FUNCTIONS:

Answer and triage incoming calls via the ACD line. Capture, review and analyze customer usage reports. Follow up on post-market customer usage and field service reports as necessary. Evaluate complaints for potential adverse events which are then forwarded to pharmacovigilance. Collaborate with colleagues globally on reports that are received from outside the US. Conduct trend analyses in order to provide and alert to changing safety and efficacy profiles on regular and ad-hoc basis. Prepare and deliver accurate reports of continuing product performance for Quality and other departments of The Company. Identify potential product performance issues and alert appropriate management personnel when needed. Initiate and coordinate investigations for complaints and support medical inquiries. Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation, and reporting of product usage experiences. Provide oversight of customer usage experiences, field feedback reports, product safety reporting, and professional consultation in matters related to safety, efficacy, and proper product functioning. Work in conjunction and effectively communicate with various departments, including Legal, Regulatory Affairs, R&D, Commercial, Pharmacovigilance, Medical Information, Customer Service, and the Manufacturing Sites. Provide clinical and technical support of marketed pharmaceutical products as needed. Provide product performance expertise on cross-functional project teams as necessary. Participate in teams concerned with development or support of products as necessary. Initiation and coordination of the Health Hazard Evaluation process. Support all field actions and coordination of the mock recall process. Provide support during Audits and Regulatory Inspections. Lead process improvement initiatives. Provide training for new hires, site personnel, and sales representatives regarding Post Market Reporting Practices as necessary.

MINIMUM REQUIREMENTS:

Education:

Bachelor's degree in clinical with a healthcare certification required (i.e. RN, RPh, PharmD, Physician’s Assistant, Nurse Practitioner, Respiratory Therapist, etc.)

Experience:

1. A minimum of five years clinical/practical experience in a relevant clinical environment required.

2. Previous Quality Assurance or Regulatory Affairs experience in the pharmaceutical and/or medical device industry is preferred

Preferred Skills/Qualifications:

1. Knowledge of FDA regulations and guidances in the area of complaint handling for pharmaceuticals, biologics and medical devices.

2. Experience interacting with regulatory agencies such as the FDA.

3. Writing skills necessary to effectively communicate technical/clinical information to others.

4. Comfortable and capable of using software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.

5. Excellent verbal and written communication skills including excellent telephone etiquette. Must be comfortable handling discussions with patients and health care providers on health and medical topics.

Skills/Competencies:

1. Committed, self-motivated team player

2. Problem solving and analytical skills.

3. An ability to effectively integrate customer and business needs in a satisfactory manner.

Other Skills/Competencies:

1. Sound organizational skills with the ability to prioritize tasks.

2. Ability to build productive relationships with personnel within and outside of the department and company.

3. Ability to work effectively in multi-functional teams.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Reports to Manager, Product Monitoring

• Frequent communication and working relationships with customers, manufacturing QA personnel, and Medical Information Specialists
• Interact with a variety of Corporate Divisions. These include, but are not limited to, Legal, Regulatory Affairs, Medical Information, Pharmacovigilance, R&D, Marketing, Quality Assurance, Sales, and Customer Service. The degree and scope will vary according to the needs of the departments involved

WORKING CONDITIONS:

• Normal office conditions, which include sitting for long periods of time and computer and phone use.
• Occasional travel may be required for such things as training seminars, manufacturing site visits, and professional/trade conventions.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

• Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project.
• Oversee the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team.
• Overseas/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
• Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy.
• Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
• Actively participates in Health Authority meetings.
• Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management.
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams.
• Effectively manages direct report(s) and provide mentorship to junior professionals.
  
  

• Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable.
• A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Pediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
• Experience in all phases of development and post marketing activities is highly preferred.
  
  

Position: Sr Project Manager - (PMP Preferred)

Location: hybrid 2-3 days onsite in Indianapolis, IN (Local candidates are given preference)

Duration: 12-24 months / long term contract

I am looking for an Operational Readiness - Sr Project Manager to join the Sterling Engineering team, supporting pharmaceutical manufacturing programs within a GMP-regulated environment.

This role will lead two major projects, each consisting of up to 13 cross-functional workstreams, requiring strong coordination across facilities, utilities, manufacturing equipment, validation, safety, and production operations.

Must have Pharmaceutical, Medical Device industry or FDA - Project Management experience - at least 10 years in the U.S.

The ideal candidate will have 10+ years of Project Management experience in pharmaceutical or regulated manufacturing environments, with demonstrated success managing large-scale, multi-workstream programs.

Projects include

• Facility modifications
• utilities systems (WFI, clean steam, HVAC)
• tank farms
• CIP/SIP systems
• manufacturing equipment installation
• validation activities tied to large capital expansion initiatives.

QUALIFICATIONS

• Project Management Certification (PMP or CAPM)
• 10+ years of U.S. Project Management experience in pharma
• Exceptional communication skills both written and verbal
• Oracle Primavera P6 utilization for project Scheduling
• Bachelor's degree in Engineering or other scientific discipline.

Why join the Sterling Team?

About us…Sterling Engineering, in business for 56 years …we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

Overview:

The Director of Product Stewardship will lead and drive strategic initiatives across the diverse portfolio at Celanese. This person will be part of the Product Stewardship Leadership Team to oversee global product stewardship efforts, ensuring compliance, safety, and sustainability.

This role offers the opportunity to collaborate with global teams, structure and transform workflows, and lead the development of processes that drive product safety and regulatory compliance consistent with our vision for world-class product safety performance. There is autonomy to scope and shape projects, make critical decisions, and work cross-functionally to support innovation, continuous improvement and compliance initiatives across the business.

This is an opportunity for a hands-on leader who can bring expertise in product stewardship and work across multiple divisions and geographies to shape the future of the organization's Product Stewardship efforts.

Responsibilities:

• Manage the Global Product Stewardship organization of approximately 30 employees in multiple regions around the world.
• Ensure global product regulatory compliance, hazard communication, product safety/product risk management across all business lines in all regions.
• Ensure Product Risk Management (PRM) process is used appropriately to mitigate risk especially in regulated end uses such as medical, pharmaceutical, food contact, etc..
• Manage the Sensitive End-Use Global group for medical, pharmaceutical, food contact support to Product Lines.
• Ensure regulatory compliance of products and raw materials in the various geographies and use markets that Celanese sells into (food contact, medical, pharmaceutical, automotive, etc.).
• Maintain proactive awareness of global emerging regulatory trends and effectively communicate business implications to business stakeholders and senior leadership.
• Develop and drive execution of compliance strategies in response to new regulatory requirements and ensure business continuity.
• Ensure product stewardship is integrated into key business processes.
• Continuously improve operational productivity of the global Product Stewardship team through regular evaluations and updates of work processes, tools, organization and staffing strategy.
• Work with Product Stewardship managers and teams to develop product stewardship goals and ensure alignment with business strategy.
• Lead product stewardship advocacy efforts in partnership with Government Affairs by building and maintaining effective partnerships with trade groups and regulatory bodies.
• Serve as work stream leader for business acquisitions, divestments and integrations.
• Communicate with customers and government authorities as representatives of the company when needed.

Qualifications:

• Bachelor's degree in engineering, chemistry, or relevant field
• 15+ total years of experience, 8+ years of experience in product stewardship
• Experience leading global product stewardship/regulatory affairs teams.
• Expertise in regulated end uses at global level particularly for food contact, medical, pharma.
• Extensive knowledge of global chemical regulatory requirements (i.e. TSCA, REACH) and industry best practices

• Deliver against a sales targets and drive business growth
• Build and maintain strong relationships with key stakeholders within hospitals, including physicians, pharmacists, hospital administrators, and formulary committees.
• Utilize knowledge of IDNs and Academic Medical Centers to navigate the complex healthcare landscape and maximize product access.
• Assist HCP champions and health system leaders in operationalizing a paradigm shifting treatment for RRP patients within their healthcare system.
• Collaborate with cross-functional teams, including marketing, sales, market access and medical affairs, to develop and implement effective sales strategies and promotional materials.
• Stay up to date with the latest clinical data, treatment guidelines, and market trends to provide accurate and timely information to healthcare professionals.
• Conduct product presentations, educational programs, and in-service training for healthcare professionals to increase awareness and understanding of our pharmaceutical products.
• Assist hospitals in the onboarding and formulary approval process by providing necessary documentation, clinical data, and value propositions to secure product inclusion.
• Monitor and analyze market trends, competitor activities, and customer feedback to identify opportunities and challenges, and adjust sales strategies accordingly.
• Provide feedback to internal teams on customer needs, market dynamics, and competitor insights to support product development and commercialization efforts.
• Maintain accurate and up-to-date records of sales activities, customer interactions, and product inventory using appropriate CRM tools.
• Develop local, regional and national KOLs in assigned territory.
• Build comprehensive account plans for top targeted IDN’s that will serve to drive strategic focus.
• Ability to travel – up to 40% of the time.
• All other duties as assigned
  
  

• Education: Bachelor's degree in a relevant scientific or business field
• Experience and/or Training:
  • Minimum of 5 years of pharmaceutical sales experience in a hospital and large IDN selling environment.
  • Strong understanding of IDNs, Buy & Bill, 340B, and the hospital formulary approval process.
  • Excellent communication, presentation, and relationship skills.
  • Proven ability to build and maintain relationships with healthcare professionals and key decision-makers.
  • Demonstrated track record of achieving sales targets and driving business growth.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and effectively in a team-oriented environment.
  • Proficiency in using CRM software and other sales productivity tools.
• Licenses/Certificates: Valid driver’s license clear of violations meeting our MVR criteria.
• Technology/Equipment: Proficiency in using CRM software and other sales productivity tools.
  

• In-depth knowledge of oncology treatments, therapeutic areas, and emerging trends in oncology, and cell and gene therapy are preferred.
• Experience in ENT/Otolaryngology experience preferred.
• Understanding of ultra-cold chain distribution is preferred.
  
  

We are currently seeking a highly motivated and experienced Quality Assurance Manager to lead our commitment to quality, operational efficiency, and excellence at MedLit Solutions in Garner, NC. As the QA Manager, you will be responsible for developing, implementing, and maintaining a comprehensive Quality Management System and play will play a key role in fostering a culture of quality, efficiency, and continuous improvement at the facility.

Responsibilities:

• Manage and maintain the site Quality Management System (QMS) in alignment with industry standards and organizational objectives.
• Lead all quality initiatives at the plant to ensure products consistently meet or exceed defined quality standards and customer expectations.
• Collaborate with cross-functional teams to identify opportunities for quality improvements, process optimization, and cost-effectiveness.
• Ensure timely investigation, resolution, and closure of quality workflows like Complaints , CAPA , NCR etc.
• Conduct internal audits and assessments to evaluate the effectiveness of the QMS and operational processes, identifying areas for improvement.
• Monitor and report on key performance indicators (KPIs).
• Ensure compliance with local regulations and industry standards applicable to pharmaceutical packaging and printing.
• Provide training, coaching, and mentorship to employees to strengthen understanding of quality principles, tools, and best practices.
• Oversee supplier quality management activities, including supplier evaluations and audits, to ensure incoming materials meet quality requirements.
• Regularly communicate with customers and internal stakeholders regarding quality initiatives and processes.
• Partner with the Plant Manager to promote a culture of quality excellence, accountability, and continuous improvement.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred.
• Minimum of 5 years of experience in quality management within the printing, packaging or pharmaceutical industries, with minimum 3 years managing direct reports and leading teams.
• Expertise in ISO 9001 (Quality Management Systems).
• Experience with FSC, SFI and PEFC certifications a plus.
• Understanding of FDA pharmaceutical and Medical Device industry regulations a plus.
• Strong analytical skills with the ability to analyze data, identify trends, and implement effective solutions.
• Excellent communication and interpersonal skills to lead and collaborate with cross-functional teams, direct reports, and stakeholders.
• Proficiency in quality management systems, data analysis tools, and software applications.
• QCBD Software Experience is a plus.
• Lean Six Sigma certification is a plus.

Why work with us? Take a look at all we have to offer!

• Paid Time Off and Paid Holidays
• Comprehensive and Competitive Medical, Dental and Vision coverage
• Company Paid Short-Term Disability Insurance and Life Insurance
• Additional Benefits -- Long-Term Disability, Supplemental Life, Accident and Critical Illness Coverage Plans
• Excellent 401(k) retirement plan with generous company contribution
• We pride ourselves in investing in our employees by offering onsite training and the ability to have unlimited growth
• potential within our organization
• We believe in rewarding our employees with performance-based salary increases

CLICK HERE to watch a video and learn more about us!

Position Summary:

The Production Manager is responsible for planning, directing, and optimizing compounding and filling operations to ensure production goals for quality, efficiency, safety, and regulatory compliance are achieved. This role combines strong technical manufacturing knowledge with leadership, operational analytics, and continuous improvement capabilities. The ideal candidate has a degree in Manufacturing Engineering (or similar), 3 years of experience in food, pharmaceutical, or cosmetic manufacturing, and demonstrated success managing complex, regulated processes.

Duties & Responsibilities:

Technical & Operational Leadership

• Lead end-to-end compound and fill manufacturing operations ensuring efficiency, throughput, quality, and safety.
• Maintain, and improve standardized operating procedures (SOPs) for compounding and filling lines.
• Oversee real-time monitoring of production metrics (e.g., throughput, yield, uptime/downtime, labor efficiency) and drive decisions based on quantitative data.
• Use ERP systems for scheduling, tracking, and reporting production performance.

Process Engineering & Continuous Improvement

• Apply Lean, Six Sigma, Kaizen, and other process improvement methodologies to reduce waste, minimize variation, and improve cycle times.
• Conduct time studies and labor analysis to optimize workforce deployment and reduce bottlenecks.
• Lead root cause analysis and corrective action implementation using structured problem-solving tools.

Quality & Regulatory Compliance

• Ensure manufacturing processes meet or exceed industry regulatory standards (e.g., GMP, HACCP, cGMP) and company quality requirements.
• Collaborate with Quality Assurance/Control to investigate deviations, manage corrective actions, and maintain compliance documentation.

Team Leadership & Development

• Manage, coach, and mentor production supervisors and operators; set performance expectations and promote accountability.
• Provide training on technical skills, process improvement tools, safety, and compliance standards.
• Foster a culture of continuous improvement, employee engagement, and high reliability.

Safety & Risk Management

• Champion strict safety protocols in line with OSHA and internal policies.
• Lead worksite risk assessments and drive improvements to minimize safety incidents.

Cross-Functional Collaboration

• Communicate production performance and improvement opportunities to senior leadership.
• Work with Warehouse supply chain, maintenance, R&D, and quality teams to ensure integrated execution of business objectives.

Required Qualifications

Education & Experience

• Bachelor’s degree in manufacturing engineering, or related technical discipline.
• 3 years of experience in a regulated manufacturing environment (food, pharmaceutical, or cosmetic), with specific exposure to compounding and filling operations.

Skills & Competencies

• Technical Proficiency: Manufacturing Engineering and manufacturing processes, filling systems, batch records, production equipment.
• Quantitative & Analytical Skills: Ability to analyze production metrics, conduct time/labor studies, and optimize operations.
• Process Improvement Expertise: Hands-on with Lean/Six Sigma tools, workflow optimization, and waste elimination.
• Leadership & People Management: Strong leadership presence; proven ability to train and develop teams.
• Time & Project Management: Prioritize tasks, coordinate cross-functional projects, and manage competing deadlines effectively.
• Communication: Clear verbal and written communication across teams and levels.
• Regulatory & Quality Knowledge: Familiarity with GMP, HACCP, or other applicable quality frameworks.

Preferred Qualifications

• Experience with ERP systems (e.g., Sage etc.).
• Certifications: Lean, Six Sigma (Green/Black Belt); HACCP or quality management credentials.
• Prior leadership of compounding and filling lines within food, pharmaceutical, or cosmetic production.