Job Title: Production Document Control Specialist I
Duration: 6 Month Contract (High possibility of extension)
Location: Durham, NC 27712
Job Summary:
Provide routine support & troubleshooting for the batch & documentation review process in production operations. Ensure that batch documentation as well as SOPs & other standardized documentation from production is in accordance with internal & external requirements. Follow-up & trouble-shoot challenges & clarifications needed to ensure high-quality batch review.
Essential Functions:
- Continuous improvement of Manufacturing processes.
- Issuance & tracking of all batch related documentation.
- Establishment & driver of batch review & documentation processes in bulk.
- APR document support.
- SOP owner review.
- Ensure real time review to include BPR, logbooks, etc.
- Ensure site compliance with cGMPs, ISO standards corporate & local SOPs.
- Review & timely approval of executed batch production records (BPRs) ensuring accurateness & compliance with approved procedures & regulations.
- Support minor deviations.
Qualifications:
- Associate's degree in technology, Science, or Pharma or equivalent industrial, military, or vocational training combined with experience required.
- Minimum of three (3) years of experience operating in a GMP regulated environment preferred.
- Minimum of three (3) years of word processing & electronic document distribution required.
- Experience with documentation in the pharmaceutical industry, like batch reports, SOPs, etc. Knowledge about requirements/expectations of regulatory authorities e.g., FDA required.
- Experience with IT systems, e.g., Adobe, Excel, SAP, material control systems, etc required.