QC Analyst

Quality Control Analyst – Environmental Monitoring

Current Responsibilities
  • 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.

Qualifications/Skills Required:
  • 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.

  • Location: San Diego
  • Type: Permanent
  • Job ID: BR8782891130