What are the responsibilities and job description for the GMP Records Specialist I position at Vita Global Sciences, a Kelly Company?
Job Title: GMP Records Specialist I
Location: Stafford, TX
Rate: Commensurate with experience
Contract length: 8 months extension
Shift: 8am-4:30pm | Mon-Fri
Position Summary/purpose
The 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 systems
Roles and Responsibilities of Position
- Perform concurrent review of GMP manufacturing documentation to ensure accuracy, completeness, and compliance
- Identify documentation errors or inconsistencies and communicate findings to the manufacturing team
- Coordinate and follow up on required document corrections across departments, shifts, and sites
- Retrieve and distribute GMP documents (batch records, labels, and supporting documentation) to manufacturing teams, ensuring availability and accuracy
- Enter and maintain documentation data within tracking systems and logs
- Support adherence to GMP documentation standards and established formatting requirements
Required Qualification (Education, Experience, Knowledge, Skills)
- Associate’s or Bachelor’s degree in Life Sciences, Biotechnology, Healthcare Administration, or related field
- Basic understanding of GMP environments or regulated industries
- Proficiency in Microsoft Word and Excel
- Strong attention to detail and organizational skills
- Ability to follow procedures and work effectively within a team environment
- Good verbal and written communication skills
Preferred Qualifications
- 1 year of experience in GMP manufacturing, documentation, or a regulated environment
- Exposure to cell therapy or biologics manufacturing
- Basic knowledge of GMP processes, equipment, and cleanroom operations
- Familiarity with batch record documentation and manufacturing workflows
Ideal Candidate Profile
- Early-career professional with strong attention to detail and interest in GMP documentation and manufacturing operations
- Reliable and process-oriented, with the ability to follow defined procedures and maintain documentation accuracy
- Strong team player who communicates effectively with peers and supervisors
- Organized and capable of managing routine tasks with consistency and accuracy
- Demonstrates initiative and willingness to learn in a regulated manufacturing