QC Associate II, Microbiology in Bristol, Pennsylvania at Abzena Inc.

• Maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties

• Perform Sample management related activities and support QC for stability pulls and testing

• Perform transfer and distribution of samples for in-coming Non-GMP and GMP samples into QC Sample Submission and appropriate laboratory

• Receive samples and track to completion of testing and filing of data packages

• Send out samples to contract labs and track results/reports.

• Perform routine and 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.

• Trending EM data and generating quarterly and yearly reports.

• Perform routine sampling and testing of pharmaceutical water systems and gas systems.

• Perform bioburden and endotoxin testing for product and in-process samples, stability samples and raw materials.

• Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.

• Support assay transfer, qualification and validation activities for clients’ specific methods as needed.

• Author final reports for assay qualifications under supervision.

• 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 as needed.

• Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.

• Minimum of B.S. degree in Microbiology or related discipline with ≥ 3 years of experience in environmental monitoring of GMP facilities.

• Minimum of three (3) years of experience working within a GMP Microbiology Lab.

• Preliminary knowledge of the theoretical and practical aspects of analytical methods utilized in microbiology labs including Bioburden, TOC, Endotoxin, Conductivity, Gram staining, and Microscopy

• Ability to gown and gain access to cleanroom and utility areas.

• Demonstrated understanding of USP, EP and FDA microbiology testing requirements.

• Strong written and oral communication skills, proficient with Microsoft Office software

• Support Microbiology staff members as needed.

FLSA: Non-Exempt

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