What are the responsibilities and job description for the Quality Assurance Compliance Specialist position at Collabera?
The Senior PQA Analyst supports day-to-day Quality Assurance activities for third-party manufacturing operations. This includes reviewing and approving manufacturing directions, investigations, supplier changes, and corrective and preventive actions. The role ensures compliance with cGMP, regulatory requirements, and internal quality standards, while serving as a liaison between regulatory areas and manufacturing sites.
Key Responsibilities:
- Maintain effective liaison with Quality, Regulatory, Technical, Supply Chain, and manufacturing sites.
- Ensure manufacturing processes at third-party sites comply with cGMP, specifications, and QA directions.
- Review and approve manufacturing directions, raw material, and laboratory investigations.
- Support global projects, including planning, risk analysis, and implementation.
- Ensure product impact analyses and corrective/preventive actions are documented accurately.
- Perform annual Product Quality Reviews in compliance with regulatory requirements.
- Monitor process trends and participate in Trend Review Boards.
- Represent manufacturing sites in Global Change Review Board meetings and evaluate supplier/process changes.
- Generate and execute change management plans to achieve intended results.
Qualifications:
- Bachelor’s degree in Engineering or Science.
- Minimum of 6 years’ experience in pharmaceutical operations, preferably biologics manufacturing.
- Strong knowledge of GMP regulations and pharmaceutical quality standards.
- Excellent analytical skills and attention to detail.
- Experience with change plans, exception reports, SAP, and LRMS preferred.
- Strong communication skills adaptable to multiple audiences.
- Effective interpersonal skills for collaboration across all organizational levels.
Pay Rate: $40/hr to $45/hr
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).
Salary : $40 - $45
