Senior Specialist, Quality Assurance

📋 Description

• Provide QA oversight during site start-up and routine cGMP ops.
• Partner with Manufacturing, Supply Chain, MSAT, Facilities, QC, and other teams.
• Review/approve material specs, Master Batch Records, SOPs, and GMP docs.
• Review/approve Deviations, CAPAs, Change Controls, and quality records.
• Support batch record review and product disposition processes.
• Provide real-time QA on the floor in manufacturing/lab envs.

🎯 Requirements

• Bachelor’s in Biochemistry, Molecular/Cellular Biology, Immunology, Biology, or related field.
• At least 8 years in an FDA-regulated industry with cGMP knowledge.
• Ability to assess risk, decide, and provide quality support in manufacturing.
• Strong knowledge of Good Documentation Practices and data integrity.
• Technical writing, investigations, analytical, problem-solving skills; strong communication.
• Ability to collaborate across functions while challenging decisions.

🎁 Benefits

• Annual salary range of $105,060–$129,780.
• Medical, dental, and vision insurance plans.
• 401(k) with 100% company match on the first 4%.
• Generous PTO.
• Employee commuter benefits.
• Cell phone stipend.