Environmental Monitoring Analyst
Location: San Diego, CA
- Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.
- Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.
- Assist in trending EM data and generate quarterly reports and yearly reports.
- Perform routine monitoring of pharmaceutical water systems.
- Perform routine monitoring of pharmaceutical gas systems.
- Perform bioburden and endotoxin testing.
- Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.
- Support assay transfer, qualification and validation activities for client’s specific methods.
- Author and review Quality Control standard operating procedures (SOPs) and assay qualifications.
- Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.
- Interact closely with other departments to ensure efficient, compliant and timely execution of project activities.
- Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.
- Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
- 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.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena’s policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena business.
- Travels as needed.
- BS degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
- Minimum two (2) years of experience in environmental monitoring of GMP facilities.
- Minimum two (2) years of experience working in a GMP microbiology lab.
- Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of cleanroom practices.
- Experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, or Gram staining.
- Knowledge of and experience in GMP, following standard test methods, or willingness to become GMP proficient.
- Ability to gown for and work in a cleanroom environment.
- Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
- Ability to use routine laboratory equipment including, but not limited to, particle counters, air samplers, microscopes, etc.
- Ability to work well under pressure, multi-task, and have good organizational and communication skills.