QC Validation Technician
Summary
Oversees and tracks validation protocols for a pharmaceutical contract development and manufacturing organization, ensuring compliance with GMP requirements and accurate execution of testing procedures.
This role will be on site. Pay for this role is $24/hour.
Position Summary: Under supervision of the Director of Validation & Quality Continuous Improvement, the Quality Control Validation Technician is responsible for the issuance, tracking, review and oversee execution of assigned validation protocols at Swiss. In addition, the validation technician will assist in authoring and gaining approval for validation documentation as requested by Validation Management.
Essential Duties and Responsibilities:
- Review and Issuance of all required Validation documentation.
- Oversee the execution of validation protocols to assure that the validation requirements are followed, and samples pulled and labeled accurately for testing.
- Tracking Validation Protocols and pertinent documentation maintaining the status for each document (i.e. Completed, in-process, final report required, obsolete, etc.)
- Organize all in-process validation/verification/qualification protocols and provide a weekly update on current status and upcoming protocol activity.
- Update validation monitoring tracking documentation for reporting to senior management.
- Provide status updates of all open protocols via validation status meeting.
- Train Operations and QC personnel on protocols before execution.
- Review and verify executed protocols to assure that all requirements are met prior to reporting.
- Coordinating with validation SMEs, quality control and production to ensure adherence to GMP requirements and alignment to overall validation strategies
- Collecting quantitative data in statistical format for use with Final Reports.
- Contributing to data, compliance and safety reviews.
- Cross training within the department stability coordinator essential duties to ensure sufficient coverage for PTO.