- Process requests for document changes utilizing the EDMS
- Process document special handling requests
- Provide department metrics to management
- Participate in documentation audits
- Process logbook requests and perform routine audits
- Process laboratory notebook requests
- Responsible for maintaining the Archive Room, including filing and assisting customers
- Identify improvements with group-level impact
- Manage assigned work and take on additional responsibilities
- Involved with other projects as required
- BA or BS in a related discipline
- Experience in auditing documentation
- Proficiency in Microsoft Word and Excel; Livelink and Microsoft Access experience is a plus.
- Able to communicate clearly and effectively through verbal and type-written correspondence; easily legible penmanship
- Strong organizational skills to coordinate multi-discipline projects
- Experience in participation in regulatory inspections is a plus
- Understanding and familiarity with FDA and European regulatory requirements and guidelines
Quality Document Control Specialist - Novato, United States - Bayside Solutions
Description
Quality Document Control Specialist
W2 Contract
Salary Range: $58,800 - $69,200 per year
Location: Novato, CA - Hybrid Role
Job Summary:
The QA Documentation Control Specialist II is responsible for maintaining the cGMP-controlled documentation system and providing the various departments with the documentation necessary to perform cGMP activities. Responsibilities include auditing existing documentation, reporting document trends to management, and managing electronic document systems.
Duties and Responsibilities:
Requirements and Qualifications:
Desired Skills and Experience
Quality Document Control, EDMS, Word, Excel, Livelink, Access, regulatory
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