Senior QA Documentation Specialist

Senior QA Documentation Specialist

W2 Contract-to-Hire

Salary Range: $104,000 - $124,800 per year

Location: Redwood City, CA - Hybrid Role

Duties and Responsibilities:

• Perform duties related to and maintain the GxP document control system, including product-related documentation, Quality Manual, external documentation, department procedures, and work instructions.
• Initiate and/or coordinate document change controls, including associated supporting documentation.
• Follow up to ensure changes are completed, properly closed out, and released in accordance with established procedures.
• Ensure controlled documents are reviewed, approved, distributed, and maintained in compliance with internal quality procedures.
• Monitor document review cycles and coordinate with document owners to ensure timely revisions, periodic reviews, and retirements as appropriate.
• Support issuance and archival of controlled documents, ensuring traceability and compliance with applicable regulations.
• Prepare and support document retrieval during inspections, audits, and regulatory submissions to ensure compliance.
• Train new users on document control systems, ensuring proper understanding of system functionalities.
• Provide guidance on document control practices and procedures to all functional departments.
• Act as a point of contact for document owners and stakeholders to ensure proper use of the document management system.
• Generate and maintain reports for document control activities, ensuring accuracy and timely completion.
• Track key performance indicators (KPIs) related to document lifecycle management, review timeliness, and change control efficiency.

Requirements and Qualifications:

• 5-7 years of relevant experience in biotech/pharmaceutical environment Quality Systems.
• Experience with Veeva QualitySuite Platforms (Veeva QualityDocs, VaultTraining, Veeva QMS).
• Bachelor of Science in Life Sciences, Engineering, or related discipline.
• Ability to work in a team environment, manage multitasking, and demonstrate discipline in completing tasks on schedule.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office skills (Word, Excel, PowerPoint).

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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