Document Control Specialist

*MUST HAVES:* * Executed batch record review (paper and eBR/MES) * cGMP and Good Documentation Practices in a manufacturing setting * Logbook auditing, reconciliation, and archival *The Role:* The Document Control Specialist – Internal Drug Product Manufacturing provides documentation oversight to ensure manufacturing records are accurate, complete, compliant, and approved on time. Reporting to the Director, Drug Product Operations, this role partners with Operations, Quality, and cross-functional teams to manage documentation from manufacturing execution through Quality approval and archival. Success is measured by on-time documentation approval, complete record reconciliation and archival, and sustained cGMP/GDP compliance. *Here’s What You’ll Do:* * Review and approve paper and electronic batch records, attachments, logbooks, forms, protocols, and other manufacturing documentation. * Ensure records meet cGMP, GDP, completeness, accuracy, and traceability requirements. * Partner with Operations, Quality, and cross-functional teams to coordinate corrections, triage, and timely record completion through final Quality approval. * Verify all required system transactions are completed and accurate prior to manufacturing record approval, ensuring alignment between executed activities, system records, and supporting documentation. * Confirm all required sampling activities, sampling plans, and sample results are completed, reviewed, approved, and closed prior to record approval. * Audit manufacturing logbooks and coordinate corrections, issuance, reconciliation, and availability within manufacturing areas. * Ensure completed manufacturing documentation is reconciled and transferred for archival. * Maintain visibility of documentation status and proactively follow up to meet established approval timelines. * Monitor applicable building and facility alarms in accordance with established procedures and assessed in a timely manner. * Escalate critical alarms, ensure timely completion and approval of impact assessments, and reconcile and archive all associated documentation. *Here’s What You’ll Need (Basic Qualifications):* * Associate or bachelor’s Degree in a Scientific field or a High School Diploma with equivalent experience. * 2-4 years in GMP manufacturing or similar environment preferred; we will train strong entry-level candidates. * Previous experience supporting GMP manufacturing documentation or document control in a pharmaceutical or biotechnology environment preferred. * Experience reviewing electronic batch records (eBR/MES) and paper batch records preferred. * Knowledge of cGMP and Good Documentation Practices (GDP). * Experience with batch records, logbooks, forms, protocols, and supporting manufacturing documentation. * Experience working with Manufacturing Operations and Quality to support documentation review and timely record approval preferred. * Drug Product or aseptic manufacturing experience is a plus. Pay: $30.62 - $40.00 per hour Application Question(s): * Application Question(s): Need 2 Slots for 5 Mint Quick Telephonic Call: Slot 1: Slot 2 Work Location: In person