QC Associate II, Microbiology

Abzena Inc.•San Diego, CA

4d•$70,000 - $85,000•Onsite

About The Position

The Quality Control Associate II is responsible for the routine, and non-routine Environmental Monitoring (EM) of manufacturing clean rooms, compressed gas system, and WFI systems. The QC Associate II will also focus on microbial testing and completion of in-process and release testing. Serves on team projects in the role of testing and investigations support. The QC Associate II is responsible for equipment setup, documentation, method transfer/qualification, training, and keeping up cGMP compliance and supports site initiatives and departmental goals.

Requirements

BS degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
3-8 years of experience in environmental monitoring of GMP facilities.
3-8 years of experience working in a GMP microbiology lab.
3-8 years of 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.

Responsibilities

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.
Utilize laboratory equipment in accordance with established practices, including, but not limited to, particle counters, air samplers, microscopes, etc.
Operate to the highest ethical and moral standards.
Adhere to quality standards set by regulations and Abzena’s policies, procedures and mission.
Communicate effectively with supervisors, colleagues and subordinates.
Participate effectively as a team player in all aspects of Abzena business.
Gown for and work in a cleanroom environment.
Accurately and precisely document and record laboratory activities, results, and conclusions.
Multi-task, organize and communicate with team.