Senior Quality Assurance Specialist II (Swing Shift) *PC 1607

The Senior Quality Assurance Specialist II provides quality assurance oversight for GMP manufacturing operations to ensure compliance with regulatory requirements, internal procedures, and quality standards.

Requirements

• Bachelor’s degree in Biology, Microbiology, Biotechnology, Chemistry, or related life science discipline.
• Minimum of 8 years of cGMP experience with at least 6 years in Quality Assurance in life sciences and late-stage biopharma industry.
• Strong experience with QA on-the-floor support and batch record review.
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements; Clear understanding of standards of practice used in the manufacture of biotechnology products
• Ability to work a swing shift schedule.

Benefits

• Health, vision, and dental insurance
• 401(k) plan