Documentation Specialist Job

DOCUMENTATION SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Documentation
- Quality
- cGMP

WHAT YOU'LL BE DOING:

- The Documentation Specialist will support the Methods Transfer, Monitoring and External QC teams and participate in ensuring documentation is accurate, traceable and conforms to applicable SOPs and regulatory requirements.
- The role is designed to support data compilation, organization of information and compliance review as necessary.
- Review the document format to ensure compliance with template requirements.
- Review protocol and report data tables against the raw data to ensure the data is accurate and traceable to the source and that the data has been accurately transcribed
- Review data calculations for accuracy
- Review document references to ensure referenced document numbers and titles are accurate, up to date, consistent in format and used consistently throughout the document
- Review protocols and reports for compliance with SOP requirements
- Identify and resolve documentation gaps/issues with team members
- Read corrected copies or proofs to ensure that all corrections have been made
- Support creation of material to train other personnel to perform document review activities.

WHAT YOU NEED TO BRING TO THE TABLE:

- M.S. degree in biological sciences, chemistry or engineering or other related fields with at least five (5) years of industry experience; or B.S. degree with at least eight (8) years industry experience
- Previous experience in the pharmaceutical industry, especially within the areas of review of analytical development, Quality Control and/or Quality Assurance documents.
- Sound knowledge of cGMPs, particularly with regards to data review and compliance
- Proficient in Microsoft Office Suite (Word, Excel, Publisher, Powerpoint, etc.)
- Ability to communicate clearly and professionally both orally and in writing

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- A familiarity in analytical method development and validation, regulatory requirements and guidelines (eg FDA, EMA) and compendia methodologies (USP, EP) is preferred.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: PROF

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