Contract GMP Records Specialist (Sr.)

Kelly Scientific is seeking a GMP Documentation SME to support a state of the art cell therapy customer near Houston, TX.

Job Title: Contract GMP Records Specialist (Sr.)

Location: Stafford, TX

Rate: Commensurate with experience

Contract length: 8 months extension

Position Summary/purpose

The Contract GMP Records Specialist (Senior Level) is responsible for the end-to-end management of GMP manufacturing documentation, including the review, authoring, and maintenance of batch records, SOPs, and associated technical documents. This role ensures documentation accuracy, data integrity, and compliance with cGMP and regulatory requirements to support manufacturing operations.

The position operates as a subject matter expert in GMP documentation, working cross-functionally with Manufacturing, Quality Assurance, and MSAT to resolve documentation issues, drive timely record completion, and improve right-first-time performance. The role also supports digital manufacturing initiatives through hands-on involvement with Manufacturing Execution Systems (MES) and/or Electronic Batch Records (EBR), including troubleshooting and continuous improvement of documentation workflows.

This is a senior-level contract role requiring independent execution, strong technical writing capability, and the ability to lead documentation-related improvements in a fast-paced GMP manufacturing environment.

• Roles and Responsibilities of Position
• Perform end-to-end review of GMP batch records and manufacturing documentation to ensure accuracy, completeness, and cGMP compliance.
• Drive timely resolution of documentation errors, coordinating directly with Manufacturing, QA, and MSAT.
• Author and revise GMP documents including Master Batch Records (MBRs), Electronic Batch Records (EBRs), SOPs, and work instructions.
• Own document changes through the change control process, including updates, impact assessment, and implementation.
• Support execution, troubleshooting, and continuous improvement of MES/EBR systems.
• Serve as SME for GMP documentation practices, ensuring adherence to data integrity (ALCOA ) and regulatory expectations.
• Partner cross-functionally to resolve documentation gaps and improve right-first-time performance.
• Maintain document tracking and support audit and inspection readiness.
• Provide guidance to manufacturing personnel on proper documentation practices and system usage.

Required Qualification (Education, Experience, Knowledge, Skills)

• Bachelor’s degree in Life Sciences, Engineering, or a related technical field.
• 6 years of GMP experience in pharmaceutical, biotechnology, or cell therapy manufacturing environments.
• Extensive experience reviewing and authoring GMP documentation, including MBRs, EBRs, SOPs, and technical instructions.
• Demonstrated ownership of document lifecycle management and change control processes.
• Hands-on experience with MES and/or Electronic Batch Record (EBR) systems.
• Strong knowledge of cGMP regulations, FDA expectations, and data integrity principles (ALCOA ).
• Proven ability to work independently, manage multiple priorities, and operate in fast-paced manufacturing environments.
• Advanced technical writing, attention to detail, and strong organizational skills.
• Effective cross-functional communication skills with Manufacturing, QA, and MSAT.

Preferred Qualifications

• Experience in cell therapy, gene therapy, or advanced biologics manufacturing.
• Direct experience with MES/EBR platforms (e.g., Werum PAS-X, Syncade, DeltaV, or similar).
• Familiarity with electronic Quality Management Systems (e.g., Veeva)
• Experience supporting commercial or late-stage GMP manufacturing operations.
• Working knowledge of deviation management, CAPA, and change control processes.
• Experience driving continuous improvement initiatives within GMP documentation systems.
• Exposure to regulatory inspections (FDA, EMA) and audit readiness activities.
• Lean Manufacturing or Operational Excellence experience.

Ideal Candidate Profile

• Senior GMP documentation SME with a proven track record of independently owning batch record review, authoring, and lifecycle management.
• Hands-on MES/EBR expert capable of troubleshooting and optimizing electronic batch record workflows.
• Highly detail-oriented with strong technical writing skills and a focus on data integrity and right-first-time execution.
• Able to operate autonomously in fast-paced, commercial or late-stage manufacturing environments.
• Strong cross-functional collaborator who can effectively partner with Manufacturing, QA, and MSAT.
• Process-driven with demonstrated ability to identify gaps and implement sustainable documentation improvements
• Comfortable supporting audits and inspections with clear, compliant, and inspection-ready documentation.