Job Purpose
The Quality Assurance Associate (MFG) in the Manufacturing area is responsible for gathering and testing in-process samples, performing clearance inspections, executing validation protocols, gathering blend uniformity samples and handling rejected material.
Essential Job Functions
Level I
- Conduct and document to GDP, QA activities related to manufacturing activities, including clearance inspections of areas, materials, and equipment.
- Maintain a clean and safe work and storage areas.
- Perform in-process sampling and testing on drug products.
- Perform clearance inspections of areas, equipment and materials.
- Perform reconciliations and yield calculations.
- Review assigned batch documents for accuracy and completeness.
- Complete logbooks, production records, and other official documentation.
- Assure reject material and retains are properly stored each day.
- Properly handle reject and retain samples.
- Entry-level training of blend uniformity sampling.
- Assure that Quality and Operations personnel are complying with GMPs and Mikart procedures.
Level II
- All activities listed in Level I
- For verifying and documenting rejected materials on the Reject Log and in batch record or other records as appropriate.
- For supervising weighing and cataloging of rejected materials from all departments, and documenting on the Reject Log and in batch record or other records as appropriate.
- For coordinating the submission of in-process and finished product samples to the appropriate lab for analysis.
- Perform blend uniformity sampling without supervision.
Job Type: Full-time