Quality Control Analyst – Environmental Monitoring
- Perform routine, non-routine environmental monitoring for viable air, viable surface, and total airborne particulates of the GMP manufacturing facilities.
- Initiate and participate in the investigations of Environmental Monitoring excursions and assess any potential impact on product quality.
- Assist in trending Environmental Monitoring data and generate quarterly reports
- Perform quantitative analysis and data analysis of in-process samples, APIs, drug products and stability samples using existing methods.
- Provide technical support in developing, optimization and validation of analytical methods to support GMP material release and in-process monitoring: HPLC, CE, PCR, SDS-PAGE, ELISA and functional assays.
- Modify or improve analytical methods as needed. Perform assay troubleshooting, including data trending and analysis.
- Support assays transfer, qualification and validation of client’s product specific methods.
- Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols.
- Maintain QC lab equipment, follow the schedules for the appropriate calibration and maintenance activities. Provide assistance as needed during IQ/OQ/PQ are needed.
- Interact closely with Manufacturing and R&D Departments.
- Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control and other duties.
- Assist in investigation and review of deviations, change controls, CAPAs, OOT/OOS thru GMP Quality System.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
- Safely operate laboratory equipment in accordance with established practices.
- BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.).
- Minimum two (2) years’ experience in Environmental Monitoring of GMP facilities.
- Minimum three (3) years’ experience working in a GMP QC lab.
- Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of Cleanroom Practices.
- Experience with one or more of the analytical methods such as: HPLC, UV/VIS, CE and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is required.
- Experience with understanding basic principles of HPLC and plate based assays such as ELISAs.
- Knowledge of and experience in GMP, following STM’s, or willingness to become GMP proficient.
- Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
- Ability to use routine laboratory equipment including, but not limited to, HPLCs, plate readers and electrophoresis equipment.
- Ability to work well under pressure, multi-task, be organized and have good communication skills.