What are the responsibilities and job description for the Quality Assurance Manager -Sterile fill Manufacturing position at Accede LLC?
The Quality Assurance Manager will lead and manage the QA team within the sterile fill and drug manufacturing environment, ensuring daily operations meet both regulatory and company quality standards.
Responsibilities
- Lead and manage the Quality Assurance team, ensuring day-to-day operations align with regulatory and company standards.
- Oversee the QA Supervisor and staff responsible for documentation review, investigation, deviation, change control, and CAPA activities.
- Ensure compliance with 21 CFR Parts 210 and 211 and maintain a robust state of inspection readiness.
- Champion data integrity initiatives and ensure all quality records are accurate, complete, and contemporaneous.
- Support regulatory inspections, client audits, and internal audit programs.
- Collaborate with Manufacturing, QC, and Engineering to address quality issues and implement effective CAPAs.
Qualifications
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, or Engineering).
- 5–7 years of experience in Sterile drug manufacturing or aseptic operations within an FDA-regulated cGMP environment.
- Strong Experience in Sterile fill operations and quality systems management.
- In-depth knowledge of FDA cGMP regulations (21 CFR Parts 210/211), ISO standards, and data integrity principles.
- 2 years in Leadership experience managing teams and supervising QA operations.