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Manager, Document Control and Quality Systems Training (cGMP) - RTP Biotech
RTP, NC 27703 United States
Documentation & Technical Writing
Our client, an RTP area biotech that is developing novel therapies in the dermatological space, is actively recruiting for a very sharp, knowledgeable and industrious candidate to join its Quality team.
This is a Direct Hire role. Company will pay excellent wage to retain an excellent candidate.
This Manager will report to the Quality Head and will be responsible for providing oversight and direction for the company’s Document Management and Training Quality Systems including:
? Controlled document processing, issuance, and change control
? Document storage and archiving
? Electronic records and data management
? Document templates
? Training programs that encourage continuous improvement and personal development
? Training materials in support cGMP regulations and practices
Specific duties will include:
? Manage the document lifecycle including document issuance, format review, routing for approval, scanning documents in Master Control EDMS and maintaining hard copy as applicable.
? Act as internal Subject Matter Expert on Master Control system. Train new users and troubleshoot as needed.
? Support departments in collecting and maintaining files necessary to support the manufacturing process (i.e., SOPs, batch records, specifications, investigations, etc.), as well as facilitate the obsolescence, cataloguing and archival process.
? Establish a complete and accurate index of company documents. Maintain paper and electronic files in the Quality document management system in accordance with Company policies and procedures, federal regulations, and audit requirements. Manage GxP retention and archival schedule as well as off-site storage vendor to archive and retrieve documents as necessary.
? Lead the implementation and company-wide training efforts in support of cGMP activities. Maintain accurate and up to date training records.
? Develop, maintain, and deliver training material in support of cGMP regulations and practices
? Lead periodic Quality audits of documents to ensure regulatory compliance, and provide support for the quality system during external/internal audits, including regulatory inspections
? Develop, maintain and report metrics to support the continuous improvement of Quality Systems
Right candidate will offer a related degree and 4+ years of directly related Document/Records Management experience in a cGMP setting. Quality Systems Training experience would be a plus. Master Control expertise (or other very similar EDMS system) will be essential. Other priorities include:
? outstanding Project Management skills
? strong compliance orientation
? keen attention to detail
? longevity and impact in previous roles
In addition, we seek a candidate who enjoys a dynamic, emerging business culture. One who thrives when empowered and brings flexibility, versatility and ingenuity to the role.
Finally and critically, as this is a highly interactive role that partners with senior level executives through entry level staff, we seek a superb communicator with proven ability to garner the cooperation of this high expectations and highly diverse constituency.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
North Carolina Biotechnology Center