Senior Q+A Specialist

Job Responsibilities:

Review and approve executed production records, production investigations, Master Production Records, COAs, and DMFs.

Review lab sample results and manufacturing records related to qualification/validation activities.

Conduct and review quality-related investigations.

Ensure cGMP compliance of assigned manufacturing operations/areas and conduct cGMP inspections.

Complete pre-campaign action items as assigned.

Responsible for the conditional/final release of materials.

Review finished product labels and prepare product trees.

Write and review Product Validation/Qualification/Assessments documents, Equipment Qualifications/Assessments documents, and Computerized Systems Validations/Assessments documents.

Review, evaluate, and approve minor equipment changes.

Conduct environmental monitoring.

Maintain QA databases for products/equipment.

MUST HAVE:

We are seeking someone with Quality System maturity who can review change controls and assess the risk they present. Experience in the day-to-day trenches of QA issues, handling resolutions, and demonstrating expertise in quality and GMP is essential. Lab experience or testing-focused individuals will not be considered.

Education and Experience:

BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience. BA/BS degree in microbiology is preferred.

Thorough knowledge of cGMP is required.

Other Requirements:

Adhere to personal moral, ethical, legal, and behavioral conduct that complies with the Organization.

Adhere to all applicable SHE and CGMP regulations.

Excellent communication skills.

Conscientious and detail-oriented.

Excellent computer skills (MS Office, WinLIMS, SAP).

Ability to work well within a team.

Self-manage daily work and set priorities effectively.

Able to manage projects and prioritize tasks appropriately.