Description:
The Quality Assurance Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products. The QA Associate is responsible for the oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
The Role
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
- Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
- Perform room and equipment clearances per procedure following cleaning conducted by production; Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
- Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
- Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
- Assist in investigations for deviations by supporting data gathering and root cause analysis
- Support site process improvements (training, efficiency projects, implementation of CAPAs); Supports customer complaint investigation by performing inspection of retains and complaint samples.
- Other duties as assigned.
The Candidate
- Bachelor's Degree; OR Associate's Degree with 1+ year of related work experience; OR HS Diploma/GED with 2+ years of related work experience.
- Lean Six Sigma, ASQ Certification, or other professional certification preferred.
- Familiarity with basic laboratory instrumentation.
- Individual may be required to sit, stand, walk for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor