Job Description

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.

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