Vacancy expired!
- Quality Assurance on the floor is responsible for coordinating, managing the floor Quality Oversight within commercial Drug Product operations to ensure sustained compliance with GMPs and regulatory readiness.
- Provides Quality oversight to operations on the shop floor. Supports manufacturing operations (upstream and downstream) in real-time.
- Assists and advises on pertinent quality issues as they arise during plant operations.
- Troubleshoot and elevate noncompliance issues and events observed.
- Demonstrates knowledge of the investigation, CAPA, and corrective action processes.
- Demonstrates ability to effectively prioritize and manage multiple project workloads
- Ensures compliance with policies and procedures
- Maintains and supports material inventory, status, and transfers.
- Performs and supports changeovers in the production area as required.
- Participates in audits and other projects as appropriate.
- Supports manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.
- Reviews documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures.
- Participates in process improvement initiatives targeting for Right First Time (RFT) on documentation.
- Participates in activities associated with event resolution and CAPAs, with a focus on organizing and attending cross-functional meetings.
- Implements and ensures adherence of appropriate regulations and quality standards.
- Supports operations to encourage a Quality Culture and ensure a safe working environment.
- Completes job-related training as required.
- 2+ years of relevant experience in a GMP environment-related field and a BS OR 3+ years of relevant experience and an AA degree.
- Prior experience in the pharmaceutical industry is preferred.
Vacancy expired!