QC Microbiology Associate I/II – Microbiology & Sample Management

QC Microbiology Associate I/II – Microbiology & Sample Management

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.

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.
• Author Quality Control (QC), standard operating procedures (SOPs) and 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.
• 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.
• Adhere to quality standards set by regulations and Abzena policies, procedures and mission.
• Communicate effectively with supervisors, colleagues and staff.
• Participate effectively as a team player in all aspects of Abzena’s business.
• Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.
• Support continuous improvement projects related to QC.
• Multitask, prioritize workload, document properly and interpret data accurately.

Preferred Qualifications

No preferred qualifications provided.