The individual in this role will be responsible for supporting site wide EM while also supporting microbiological assays, OOS investigations, and validation report writing/execution Person in this position will work in a cGMP environment using aseptic technique.
- Gathers, processes, and analyzes environmental samples for use in facility qualification and routine environmental monitoring (EM). Must be able to aseptically gown and work in a cleanroom setting for the duration of a complete shift.
- Supports Aseptic Process Simulations (APS) by performing EM, supervising staff, and preparing paperwork for APS.
- Tests the sterility of both the finished drug product and samples taken throughout the manufacturing process for endotoxins and microbiological media.
- Conducts basic instrument maintenance, calibration, and quality control.
- Conducts efficacy tests on disinfectants and takes part in cleaning validation.
- Exhibits knowledge of the related technical papers' writing and review processes, as well as regulatory, compliance, and validation problems.
- Charged with informing the appropriate QC groups with essential information, such as production schedules and information requests.
- Creates Standard Operating Procedures through change control and carries out project-related duties as assigned under clear guidance.
- Puts a priority on good documentation practices when writing, reviewing, and/or approving test records and forms, sampling plans, and specifications (GDP).
- Educates other lab analysts on standard test procedures.
- Collaborates with Quality Assurance to develop protocols and activities for new materials and equipment validation qualification. Can take part in the execution of these protocols as required to assist production and lab operations.
- Aids in the preparation of answers to audits, deviations, out of specification (OOS) inquiries, and corrective/preventative measures (CAPA).
- Finishes data analysis and summary reports for trend reports that are scheduled.
- Complies with all training requirements and helps colleague analysts with their training.
- Follows security and safety protocols.
- Executes additional tasks