GMP Records Specialist (Sr.)

About the role

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.

Responsibilities

• 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.

Qualifications

• 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.

Benefits

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.