Documentation Coordinator

GlaxoSmithKline is hiring Documentation Coordinator.

Basic qualifications:

  • Associate’s Degree
  • 3-5 years experience in GMP environment with emphasis on computers.
  • Proficiency in Microsoft Word, Excel, and Outlook
  • Experience authorizing GMP records

Preferred qualifications:

  • Bachelor’s Degree
  • Experience in a pharmaceutical environment
  • Knowledge of GMPs and experience authorizing SOPs and using batch records.
  • Knowledge of regulatory requirements related to documentation.
  • Ability to handle multiple priorities
  • Written and verbal communication skills
  • Experience working in a team environment and collaboration with others
  • Experience with statistical analysis.
  • Proficiency in LIMS and TrackWise.
  • Experience with project work, specifically utilizing Lean Sigma skills

Details:

GSK in Aiken, South Carolina is currently seeking a Documentation Coordinator. The Documentation Coordinator is responsible for the coordination of all Quality documentation changes and issuance of new documentation.

Key Responsibilities:

  • Provide support for master documentation issuance and reconciliation.
  • Issue and maintain site SOPs, Quality Department Standard Ways of Work and manage document change requests.
  • Develop and update Quality Department SOPs.
  • Perform training to associates on master documentation and standard operating procedures.
  • Review and approve Master Batch Records.
  • Review Master Manufacturing instructions in accordance to Master Batch Records.
  • Manage documentation and retain storage archival and destruction.
  • Review production records in accordance with cGMP procedures.
  • Fill documentation requests from markets.
  • Perform monthly cGMP walkthrough’s.
  • Assist in Periodic Product Reviews.
  • Support GSK Aiken as a contributing Quality Compliance Team Member.• Adhere to all GSK safety guidelines and procedures.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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