Job Summary:
Provide QA support for the Manufacturing and Production departments and to fulfill the compliance responsibility for incoming raw materials and packaging components. The QA Specialist II will closely monitor and verify GMPs, and SOP processes are being followed in all manufacturing areas.
Primary Responsibilities/Activities:
- Sampling and Inspection of raw materials and packaging components.
- Provide QA support for the Manufacturing and Production departments and overall Operations.
- Provide line clearance/line start up.
- Monitor manufacturing and production processes to ensure compliant with cGMPs and SOPs.
- Routine inspection of warehouses, reject cage, quarantine area, waste area, production and manufacturing areas to ensure state of cGMP compliance.
- Issue and monitor label and critical components of products.
- Perform reconciliation of batch components.
- Perform Batch record review as needed.
- Maintain temperature-monitoring logbooks for storage facilities.
- Inspection of contract finished product.
- Perform balance calibration as necessary and assist manufacturing team when necessary.
- Assist with Preventive Actions, Root Cause Analysis and Countermeasures within the QA Department.
- Review, monitor ERP system for accuracy for raw materials, packaging components, and finished product.
- Review, revise, update, and or create SOP/specification documents or other GMP documents as needed.
- Maintain the reserve sample room.
- All other duties assigned.
Qualifications:
- Education: 4 year Degree Preferred with science / engineering or equivalent discipline focus
- Experience: knowledge of cGMP’s and experience in manufacturing preferred. Knowledge and experience in writing/ revising SOPs and supporting documents in a QA role
- Specialized knowledge or training: understanding metrics and quality control / excellent writing and verbal communication skills / attention to detail a must / proficient with MS Word / Microsoft programs / computer skills / ability to work well as a team / flexibility and adaptability to changing schedule and tasks/ ability to work under limited supervision
- Travel required in this position None
