GMP Records Specialist I

Job Title: GMP Records Specialist ILocation: Stafford, TX Rate: Commensurate with experience Contract length: 8 months + extension Shift: 8am-4:30pm | Mon-Fri Position Summary/purposeThe GMP Records Specialist I is responsible for the review and coordination of GMP manufacturing documentation to ensure accuracy, completeness, and compliance with established procedures and regulatory requirements. This role supports manufacturing operations by performing concurrent documentation review, identifying discrepancies, and facilitating timely corrections across teams.The position requires strong attention to detail, basic knowledge of GMP documentation practices, and the ability to follow defined processes in a structured environment. The specialist works closely with Manufacturing and Quality teams to support compliant execution of batch records and maintain accurate documentation within tracking systemsRoles and Responsibilities of PositionPerform concurrent review of GMP manufacturing documentation to ensure accuracy, completeness, and complianceIdentify documentation errors or inconsistencies and communicate findings to the manufacturing teamCoordinate and follow up on required document corrections across departments, shifts, and sitesRetrieve and distribute GMP documents (batch records, labels, and supporting documentation) to manufacturing teams, ensuring availability and accuracyEnter and maintain documentation data within tracking systems and logsSupport adherence to GMP documentation standards and established formatting requirementsRequired Qualification (Education, Experience, Knowledge, Skills)Associate’s or Bachelor’s degree in Life Sciences, Biotechnology, Healthcare Administration, or related fieldBasic understanding of GMP environments or regulated industriesProficiency in Microsoft Word and ExcelStrong attention to detail and organizational skillsAbility to follow procedures and work effectively within a team environmentGood verbal and written communication skillsPreferred Qualifications1+ year of experience in GMP manufacturing, documentation, or a regulated environmentExposure to cell therapy or biologics manufacturingBasic knowledge of GMP processes, equipment, and cleanroom operationsFamiliarity with batch record documentation and manufacturing workflowsIdeal Candidate ProfileEarly-career professional with strong attention to detail and interest in GMP documentation and manufacturing operationsReliable and process-oriented, with the ability to follow defined procedures and maintain documentation accuracyStrong team player who communicates effectively with peers and supervisorsOrganized and capable of managing routine tasks with consistency and accuracyDemonstrates initiative and willingness to learn in a regulated manufacturing