Sr QC Associate, Microbiology & Sample Management
About The Position
With extensive experience in developing biologics and bioconjugates, Abzena offers a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, they find the best solution and use the right technologies to design, develop and manufacture products to ensure vital medicines reach patients quickly and safely. Abzena is dedicated to quality excellence and driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. Abzena is more than a CDMO, they are a responsible and dedicated partner that takes care of products from concept to patient. The Quality Control Senior Associate, Microbiology & Sample Management, is responsible for performing routine and non-routine Environmental Monitoring (EM), routine testing of incoming raw materials, product (in-process, release, and stability) in support of GMP manufacturing at Abzena. The Senior Associate will also be responsible for the receipt, control, and disposal of GMP samples submitted to the QC lab.
Requirements
- Minimum of a B.S degree in Microbiology or related discipline with ≥5 years of experience in environmental monitoring of GMP facilities.
- Minimum of three (5) years of experience working within a GMP Microbiology Lab.
- Knowledge of theoretical and practical aspects of analytical methods utilized in microbiology labs, including Bioburden, TOC, Endotoxin, Conductivity, Gram staining, and Microscopy.
- Experience with the transfer and qualification/ validation of large molecule focused methods.
- Experience with preparing test reports, qualification/validation protocols, and SOPs.
- Ability to gown and gain access to the cleanroom and utilities areas.
- Ability to author excursion reports, trend reports, qualification/ validation protocols, qualification/validation reports, CAPAs, and SOPs as needed.
- Demonstrate 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
- Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.
- Gown for and work in a cleanroom environment.
- Perform routine monitoring of pharmaceutical water systems.
- Perform routine monitoring of pharmaceutical gas systems.
- Perform bioburden and endotoxin testing.
- Initiate and participate in the investigations of EM excursions, deviations, and out of specifications. Assess any potential impact on product quality.
- Author and execute qualification/validation protocols. Author qualification/validation reports.
- Assist in trending EM data and generate quarterly reports and yearly reports.
- Performs stability set downs and pulls, Reference Standard pulls, and maintains documentation associated with stability pulls and Reference Standard/ sample traceability.
- Perform analysis of in-process samples, APIs, and stability samples using existing methods.
- Support assay transfer, qualification and validation activities for client’s specific methods.
- Receive, log, inventory, and transfer/distribute incoming Non-GMP (if applicable) and GMP samples into QC Sample Submission and appropriate laboratory.
- 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.
- Initiates purchase and shipment requests and outsource sample submission forms for outsource testing.
- Accurately and precisely document and record laboratory activities, results, and conclusions.
- Provides review of compendial testing data and associated documentation.
- Author and review Quality Control standard operating procedures (SOPs)
- Adhere to quality standards set by regulations and Abzena’s policies, procedures and mission.
- Communicate effectively with supervisors, colleagues and subordinates.
- Follow best practices related to the systems and processes that support the practices and documentation in the GMP facility for manufacturing clinical material
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
