GlaxoSmithKline is hiring Documentation Coordinator.
- 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
- 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
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.
- 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.
You may apply for this position online by selecting the Apply now button.
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