Quality Assurance Technician
Role Summary
The Quality Assurance Technician is responsible for the assurance of proper GMP activities within the Lupin Somerset manufacturing and packaging facilities. This position is responsible for working in production, warehouse, process rooms, and packaging lines to evaluate all manufacturing activities meet the acceptance criteria. Currently seeking candidates in 2nd shift (2:00 p.m. - 10:15 p.m. )
Essential Duties and Responsibilities
- Sample, inspect incoming raw materials, in-process intermediates, and purchased finished products and submits samples to the Quality Control laboratory for analysis.
- Label the material status from Quarantine from Release to reject and vice versa.
- Monitor the manufacturing equipment and rooms and packaging lines/ equipment for cleanliness and approve them before the start of the operation
- Perform Quality Assurance in-process checks (Beginning, Middle, and End) for manufacturing and packaging operations and determine the results meets against pre-determined standards and batch record requirements.
Conduct Acceptable Quality Limit inspections on finished dosage forms against pre-determined Quality Attributes. - Collect and maintain Quality Assurance Retain samples from all products manufactured.
- Assure that all retains are stored appropriately for accountability, annual inspection, and retrieval.
- Sample and proofread all pharmaceutical labeling for conformance to the standard.
- Issues approved Labels to the packaging lines for use.
- Inform immediately any manufacturing/packaging issue to the Quality Assurance supervisor.
Education & Experience
- Associate Degree or Bachelor’s Degree in a scientific field is preferred
- 3+ years' experience in a Quality Assurance role in the pharmaceutical industry
- Knowledge of the pharmaceutical manufacturing and/or packaging process
- Excellent communication skills
- Attention to detail is paramount
- Desire to achieve a high quality of work and diligent about following
- Standard Operating Procedures
- Knowledge of Good Manufacturing Practices