Quality Engineer II
About The Position
The QA Engineer II is responsible for ensuring QA System compliance and capability through ownership, development, implementation, and continuous improvement of quality systems within the site. The QA Engineer II is responsible for the daily QA lab activities and staffing. Key areas of the role are: Development, Implementation and Management of Quality Systems at the Site. • Owner of the sites quality systems to ensure compliance to the corporate quality system and site procedures. Document Control Site System Owner Internal Audit Program Owner Mock Recall & Traceability Process Owner Corrective & Preventative Action System Owner QMS Training Lead for the site Electronic QMS System Key User for the site Others as assigned by QA manager • Provides updates and ongoing health checks of the processes. • Supports plant goals by implementing systems to support continuous improvement. Leads/Supports All Internal and External Quality Audits. Internal Audit Owner GMP Monthly Inspection (Coordination and Metrics) Leads / Supports External Audits as required. Enhancing Operations Quality Capability & Ownership through Training, Coaching and Supporting Provides site wide quality systems training, coaching and support Leads the transfer of identified quality systems to the QA Technicians by providing system development, training and ongoing coaching Leads various elements of the process control strategy Backup product release support as needed Serves as the backup to the QA manager as needed Continuous Improvement Lead continuous improvement activities including transferring from a heavy product testing to online capability controls Work across other sites to standardized best in class approaches / processes Leads lab operations and supervises lab personnel Perform other duties as assigned.
Responsibilities
- Development, Implementation and Management of Quality Systems at the Site.
- Owner of the sites quality systems to ensure compliance to the corporate quality system and site procedures.
- Document Control Site System Owner
- Internal Audit Program Owner
- Mock Recall & Traceability Process Owner
- Corrective & Preventative Action System Owner
- QMS Training Lead for the site
- Electronic QMS System Key User for the site
- Provides updates and ongoing health checks of the processes.
- Supports plant goals by implementing systems to support continuous improvement.
- Leads/Supports All Internal and External Quality Audits.
- Internal Audit Owner
- GMP Monthly Inspection (Coordination and Metrics)
- Leads / Supports External Audits as required.
- Enhancing Operations Quality Capability & Ownership through Training, Coaching and Supporting
- Provides site wide quality systems training, coaching and support
- Leads the transfer of identified quality systems to the QA Technicians by providing system development, training and ongoing coaching
- Leads various elements of the process control strategy
- Backup product release support as needed
- Serves as the backup to the QA manager as needed
- Lead continuous improvement activities including transferring from a heavy product testing to online capability controls
- Work across other sites to standardized best in class approaches / processes
- Leads lab operations and supervises lab personnel
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
