QA Documentation Specialist

𝗛𝗶𝗿𝗶𝗻𝗴: 𝗤𝗔 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁

𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻: New Hampshire Seacoast, NH

We are looking for a strong GMP QA Documentation Specialist to support quality and compliance activities in a regulated environment. The ideal candidate will have experience reviewing and approving controlled documents, validation/qualification records, equipment and instrumentation documentation, and computerized or analytical systems documentation.

𝗞𝗲𝘆 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀:

• Review and approve controlled GMP documents for accuracy, completeness, and compliance

• Review validation and qualification protocols, reports, and records

• Review equipment, instrumentation, computerized, and analytical systems documentation

• Ensure compliance with GMP and Good Documentation Practices (GDP)

• Identify and resolve documentation discrepancies and compliance issues

• Support SOPs, work instructions, forms, specifications, and other controlled documents

• Support change controls, deviations, CAPAs, and quality-system activities

• Collaborate with QA, Validation, Engineering, Manufacturing, QC, IT, and other teams

• Support audit and regulatory inspection readiness

𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀:

• Strong experience in a GMP-regulated pharmaceutical, biotech, medical device, or similar environment

• Experience reviewing and approving controlled GMP documentation

• Experience with validation and qualification documentation

• Knowledge of equipment/instrumentation and computerized or analytical systems documentation

• Strong understanding of GMP/GDP requirements and document control

• Excellent attention to detail, communication, organizational, and problem-solving skills

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Pharmacy, Engineering, Quality, or related field preferred