QC Associate I, Microbiology
About this role
Description
Summary
The Quality Control Associate I, Microbiology is responsible for performing routine environmental and utilities monitoring of the cGMP manufacturing facilities. Conducts microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include assisting with data trending, supporting method validation activities, and contributing to the drafting of protocols, reports, and SOPs related to microbiological operations. The role also involves timely and compliant reporting of test results and participation in investigations as needed.
Job Responsibilities
Essential Functions
- Conduct Bioburden and endotoxin testing of in-process and products samples.
- Perform environmental monitoring (EM) of classified cleanrooms and controlled areas.
- Collect and test water samples from purified water and WFI systems.
- Maintain accurate and compliant documentation in accordance with cGMP, GDP, and internal SOPs.
- Assist in investigations of microbiological deviations and support CAPA implementation.
- Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
- Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements.
Supplemental Functions
- Other duties as assigned.
Requirements
Education and Experience
- BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience.
- BS with 0-2 years of progressively responsible experience in pharmaceutical or biologics production environments, or equivalent combination of education and experience.
Knowledge, Skills, and Abilities
- Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
- Knowledge of standard laboratory equipment.
- Basic understanding of microbiological techniques, aseptic practices, and laboratory safety.
- Good organizational and problem-solving skills.
- Ability to follow written procedures and work in a regulated environment.
- Must always adhere to good documentation practices.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Willingness to work in cleanroom settings and handle biohazardous materials under proper PPE and gowning protocols.
- Experience with Microsoft suite (e.g. PowerPoint, Word, and Excel).
Company at a glance
Bora Biologics: Accelerating Success in Biologics Development
With a proven track record of over 100 successful cGMP manufacturing batches and the development of more than 42 biologics and biosimilars, Bora Biologics exemplifies how experience drives success. We offer agile, comprehensive end-to-end CDMO solutions that optimize time and cost efficiencies for biopharma companies around the world.
Leveraging our global CDMO capabilities, our state-of-the-art, FDA-registered facility in the U.S., and our deep expertise in biologics development and manufacturing, we provide efficient and effective pathways to market for clients.
We specialize in a diverse range of biologics, including monoclonal antibodies (mAbs), bi-specifics, fusion proteins, recombinant proteins, and enzymes. From cell line development to commercial manufacturing, our team brings extensive global and regional regulatory affairs expertise to ensure compliance and success at every stage of the process.
- Mammalian and Microbial GMP Manufacturing
- Early, Late-Stage and Commercial Production
- Integrated Process and Analytical Development
- Formulation and Drug Product Development
- Quality Control and Assurance
State-of-the-Art Facilities & Highlights
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Bora Biologics | San Diego, California, USA
+FDA Registered
+130,000 sf GMP and R&D space
+14,000 sf temperature controlled GMP warehouse
+Single-Use Bioreactors (SUBs): 2 x 50L, 2 x 250L, 4 x 1000L , 2 x 2000L (in plan)
+Stainless Steel Fermentors: 1 x 150L, 1 x 300L (SUF)
+3 GMP suites
Bora Biologics | Zhubei City, Taiwan
+70+ cGMP batches with 100% success rate continuously since 2014
+48,000 sf of GMP and R&D space
+cGMP, ICH, FDA, EMA, TFDA, PIC/S
+Single-Use Bioreactors (SUBs): 2 x 50L, 4 x 500L (2 in plan)
Partner with us today to discover how our EXPERIENCE can accelerate your success.
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