QC Associate II, Microbiology

Abzena Inc. • Bristol, PA

1d • $72,000 - $82,000 • Onsite

About The Position

The Quality Control Associate I/II, Microbiology & Sample Management is responsible for routine testing of incoming raw materials and products (e.g. in-process, release, stability, etc.) in support of GMP manufacturing at Abzena. Focus areas include execution of environmental monitoring program, routine microbiological testing and documentation/data review of QC microbiology generated results. The QC Associate will perform a variety of responsibilities associated for sample management program.

Requirements

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level