Senior Specialist, Quality Assurance (QA) – QC Instruments

Tasks

• Review and approve QC instrument qualification and validation documentation
• Ensure compliance with Good Documentation Practices and quality procedures
• Review deviations, change controls, CAPAs, and QC equipment records
• Support audit and inspection readiness
• Maintain documentation accuracy, data integrity, and regulatory compliance

Requirements

• 3–8 years of CQV / Equipment Qualification experience in biotech, biopharma, or regulated GMP environments
• Strong knowledge of GxP/GMP compliance and data integrity
• Hands-on experience with Deviation Management, Change Control, and CAPA
• Experience reviewing and approving validation/qualification protocols and reports
• Bachelor's degree in Biology, Chemistry, Microbiology, Engineering, or a related field
• QC laboratory instrument/equipment experience (Nice to Have)
• Knowledge of FDA, EU, and ICH guidelines (Nice to Have)
• Experience with Kneat or similar validation documentation tools (Nice to Have)
• Familiarity with analytical or microbiological QC testing (Nice to Have)

How to apply

• Comment “INTERESTED”, email your resume, or message me directly on LinkedIn.

Location

• Southwest #Boston, MA
• Onsite