QA Documentation Specialist I

Posted 19 days ago

tekwissenVacaville (CA)

Quality Control Analysts Pharmaceutical Preparation Manufacturing

SENIORITY

Senior

SALARY

$20 to $25 per hour

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About the role

Job Title: QA Documentation Specialist I

Duration: 6 Months

Job Type: Contract

Work Type: Onsite

Shift: Monday to Friday from 08:00 AM to 05:00 PM

Pay Range: $20 to $25 per hour

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world‑class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Summary: We are looking for a motivated and detail‑oriented Quality Systems Support Specialist to join our Vacaville, CA team. The role focuses on supporting Quality System Management through document control activities and PQS integration, ensuring full compliance with cGMP and global regulatory requirements.

Responsibilities: Support implementation, execution, and maintenance of PQS integration and Quality Documents in Veeva for the Vacaville site. Collaborate with the Quality Document Control group to complete workflows, manage document gating, and coordinate document change processes to minimize operational impact. Initiate and manage documents in Veeva Quality Docs. Format and edit controlled documents. Track and log source document requests. Ensure all activities comply with cGMP and global quality requirements. Maintain a high level of inspection readiness at all times.

Required Skills: 1–3 years of experience in Quality within the pharmaceutical or biopharmaceutical industry (supplier quality experience preferred). Strong ability to collaborate within diverse, cross‑functional teams. Experience with Veeva Quality Document Management System and Microsoft Teams. Technical writing experience. TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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