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A4398- cGMP Document Control Lead (ONSITE)
Netsource - Wilson, NC
posted about 2 months ago
About the position
The cGMP Document Control Lead is a critical role responsible for overseeing the electronic document control process within a cGMP regulated environment. Initially remote for the first six months, the position will require travel to Pennsylvania sites and potentially to Ireland for training. After this period, the role will transition to a full-time onsite position in Wilson, NC. The ideal candidate will have extensive experience in engineering documentation control, particularly in large capital projects, and will be tasked with ensuring the timely review and approval of engineering documents and drawings.
Responsibilities
- Define and develop an electronic EDC process to ensure all documents and drawings are digital only.
- Ensure correct definition of Supplier Documentation Index (SDI) for all Vendor and Trade packages.
- Coordinate review and approval of engineering drawings and documents.
- Ensure timely signoffs of turnover packs as per project schedule requirements.
- Expedite closure of all queries and comments from document reviews.
- Adhere to project schedule targets for documentation handover phases.
- Upload documents progressively to level load the review and approval process.
- Track progress using KPIs related to document submissions and approvals.
- Manage an Issue Resolution tracker for potential issues and delays.
- Audit VTOP/TTOP content quality to ensure alignment with expected standards.
- Ensure accurate upload of all turnover packs, drawings, and P&IDs to Meridian.
Requirements
- Bachelor's degree in Engineering or related field.
- At least 10 years of experience in Engineering Document Control (EDC).
- Proven track record within a cGMP regulated environment.
- Experience with large capital projects as an EDC Lead.
- Strong planning and organizing skills.
- Excellent interpersonal and influencing skills.
- Strong written and oral communication skills.
Nice-to-haves
- Experience with Digital EDC systems.
- Strong knowledge of EDC processes and procedures.
- Ability to work under pressure and meet deadlines.
- Ability to coordinate with colleagues, contractors, and consultants.
- Strong initiative and proactive task identification.
Benefits
- Competitive hourly pay of $94 - $95.
- Full-time contract position with a structured schedule from Monday to Friday.
