What are the responsibilities and job description for the QC Microbiologist I/II position at Abzena Inc.?
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Quality Control Associate I/II, Microbiology is responsible for routine testing of incoming raw materials and product, (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 in both a team and individual setting.
Responsibilities
- Maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties.
- 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.
Qualifications
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
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
