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:
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
Requirements and Qualifications:
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
Desired Skills and Experience
Quality Document Control, EDMS, Word, Excel, Livelink, Access, regulatory
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