Document Control Specialist

Title: Document Control SpecialistLocation: Norwood, MA – 100% OnsiteEmployment Type: ContractStatus: Accepting CandidatesAbout the RoleThe Document Control Specialist will provide documentation oversight for internal drug product manufacturing, ensuring manufacturing records are accurate, complete, compliant, and approved on time. This role partners with Operations, Quality, and cross-functional teams to manage documentation from manufacturing execution through Quality approval and archival.Key ResponsibilitiesBatch Record & Documentation ReviewReview and approve paper and electronic batch records, attachments, logbooks, forms, protocols, and other manufacturing documentationEnsure records meet cGMP, GDP, completeness, accuracy, and traceability requirementsVerify required system transactions are completed and accurate prior to manufacturing record approvalConfirm required sampling activities, sampling plans, and sample results are completed, reviewed, approved, and closed prior to record approvalDocument Control & ArchivalPartner with Operations, Quality, and cross-functional teams to coordinate corrections, triage, and timely record completionAudit manufacturing logbooks and coordinate corrections, issuance, reconciliation, and availability within manufacturing areasEnsure completed manufacturing documentation is reconciled and transferred for archivalMaintain visibility of documentation status and proactively follow up to meet established approval timelinesManufacturing ComplianceSupport documentation compliance within a cGMP manufacturing environmentMonitor applicable building and facility alarms in accordance with established proceduresEscalate critical alarms and ensure timely completion and approval of impact assessmentsReconcile and archive all associated alarm documentationQualificationsAssociate or Bachelor’s Degree in a Scientific field, or High School Diploma with equivalent experience2–4 years of experience in GMP manufacturing or a similar environment preferredPrevious experience supporting GMP manufacturing documentation or document control in a pharmaceutical or biotechnology environment preferredExecuted paper and electronic batch record review (eBR/MES)Knowledge of cGMP and Good Documentation Practices (GDP)Experience with batch records, logbooks, forms, protocols, and supporting manufacturing documentationExperience working with Manufacturing Operations and Quality to support documentation review and timely record approval preferredPreferred QualificationsExperience reviewing electronic batch records (eBR/MES) and paper batch recordsLogbook auditing, reconciliation, and archival experienceDrug Product or aseptic manufacturing experienceStrong documentation review and organizational skillsStrong ability to coordinate with Manufacturing Operations and QualityStrong entry-level candidates may be considered and trainedCompensation$35–$40/hrNorwood, MA – 100% OnsiteMonday–Friday, 8:00 AM–5:00 PM6+ Month Contract