Senior Quality Assurance Specialist I (Swing Shift) *PC 1605

The Senior Quality Assurance Specialist I is responsible for supporting QA on-the-floor manufacturing activities, batch record review, and quality system processes to ensure operations are conducted in accordance with current Good Manufacturing Practices (cGMP). The position requires the ability to support swing shift manufacturing operations and occasional weekend work.

Requirements

• Bachelor’s degree in Biology, Microbiology, Biotechnology, Chemistry, or related life sciences field
• A minimum of 5 years’ of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment
• Strong experience with QA on-the-floor support and batch record review
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements

Benefits

• Health insurance
• Vision insurance
• Dental insurance
• 401(k) plan