What are the responsibilities and job description for the Laboratory Quality Assurance Specialist position at Planet Pharma?
Job Description:
We are seeking a highly motivated and detail-oriented Laboratory Quality Assurance Specialist to join our team at Planet Pharma.
About the Role:
- The successful candidate will be responsible for facilitating the incoming sample receipt and accessioning flow, deciphering batch assignments across all assay types in accordance with best practices.
- They will execute microbiological and/or analytical methods to facilitate in-process testing under cGMP guidelines, contributing to prompt result reporting to meet internal customer requirements.
- The specialist will perform environmental monitoring sampling and testing of facilities, equipment, and utilities, evaluating completed assay validity, calculating and summarizing results, and analyzing data per expected ranges.
- They will assist with trend analysis report compilation and verification, perform general housekeeping activities, and collaborate with colleagues to ensure laboratory maintenance systems are adequate for inspection readiness.
- The role also involves assisting with supply and critical reagent inventory control, growth promotion of media, microbial identification testing, and providing on-call coverage to support QC laboratory equipment functionality.
- The ideal candidate will exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, performing investigation record initiation within required timeframes.
- Additionally, they will provide input or assay support to test method validation, investigations, technical studies, and method transfer protocols, attending team huddles and department meetings to generate ideas for laboratory infrastructure improvements and method optimization.
