Production Document Control Specialist I Job at Compunnel Inc., Durham, NC

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  • Compunnel Inc.
  • Durham, NC

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.

Job Tags

Contract work, Local area,

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