2 Corporate Drive, 2nd Floor
South San Francisco,
Industry: Clinical & Scientific
Job Number: 16091
Bayside Solutions is currently recruiting for a QA Documents Specialist, reporting to the QA Manager. This position will be based in South San Francisco.
The ideal candidate is an experienced Documents Control Specialist with a track record of success in a GMP environment. The job incumbent will be responsible for updating and filing company documents, logs, and data in support of regulated activities. The candidate should understand Chain of identity controls needed to support autologous cell therapy. In addition, the Document Control Specialist will coordinate the review and revision of existing procedures, specifications and forms as well as act as central archivist for regulated documentation.
The ideal candidate is meticulous and detail-oriented, a self-starter and can work independently. The candidate should understand the requirements of 21 CFR Part 11 as it pertains to electronic records and support documentation systems. This candidate will work across multiple functional areas and operations to facilitate controlled document reviews and provide routine document lifecycle tracking reports to management. The Document Control Specialist will train personnel on document format and standards, content, use, control, as well as identify system improvements where needed.
Thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, Adobe and PowerPoint. Excellent verbal and written communication skills. Ability to build strong working relationships with multiple departments.
- Candidate must hold bachelor’ s degree or higher in relevant biological sciences.
- Highly goal-driven approach and the ability to focus on time-sensitive objectives.
- 4+ years in industry with GMP/GLP quality assurance/control experience.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.