Overview
Associate II, QC Microbiology Jobs in Waltham, USA at ElevateBio
Elevate Bio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry‑leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role
The QC Associate II will support a wider range of QC Microbiology activities in the cleanroom and laboratory at our Base Camp facility in Waltham. In this role, you will be responsible for ensuring daily functions and responsibilities of the QC Microbiology group within the laboratory and clean rooms are completed accurately and efficiently. This role will also support associated quality events and reports in support of Elevate Bio’s programs.
What
You’ll Do
- Perform routine microbial tests, analyze results, and record data/report in LIMs systems
- Perform routine entry/review into QMS Systems
- Veeva, Kneat
- Perform routine cleanings of QC Microbiological Equipment and document it via CMMS Systems
- BRAM, SAP
- Lead laboratory investigations associated with excursions
- Lead No impact/Minor Quality Events
- Deviations
- Support investigational work associated with quality events
- CAPAs, change controls and OOSs.
- Collaborate with other QC functions to ensure all testing is completed within established timelines.
- Revise QC Microbiological test methods and SOPs.
- Support QC Microbiological VALPs and VALRs.
- Assist in training.
Requirements
- Bachelor’s degree in a technical discipline (biology, chemistry, microbiology, engineering or related field) with 2–4 years of experience in a GMP quality‑control microbiology lab setting.
- Ability to communicate and work collaboratively across departments and within a team, as well as to complete routine tasks independently.
- Excellent organizational skills and attention to detail are required.
- Experience with QC microbiological test methodologies
- Examples: environmental monitoring, endotoxin, sterility, bioburden, growth promotion, TOC/conductivity, and associated water bioburden.
- Ability to follow and execute SOPs, with an understanding of procedural structure and the theory behind the methodology.
- Experience with laboratory investigations and deviations.
- Knowledge of GMPs, SOPs, GLP and quality‑system processes.
- Environmental monitoring as it applies to USP/ISO/EU regulations.
Skills & Competencies
- Experience with rapid microbiological techniques involved with cell and gene therapy is a plus.
- The Endosafe Nex Gen‑MCS
- BACT/ALERT 3D system
- Experience in environmental monitoring and/or utilities monitoring is a plus.
- Experience in routine microbial testing is a plus.
- Experience with MODA, Veeva, Kneat, SAP, and BMRAM is a plus.
Work Environment & Physical Demands
- Routine weekend work required
- Wednesday – Saturday (10‑hour shift)
- Sunday – Wednesday (10‑hour shift)
- Able to lift and carry 20 lbs (equipment/materials)
- Ability to be on feet for 4 hours at a time
- Ability to aseptically gown
- Able to support off‑shift hours for product testing
Reporting Structure
Reports to QC Microbiology Management.
The budgeted range for this position is $38/hour – $52/hour. This range is a good‑faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
Elevate Bio is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Elevate Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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Title: Associate II, QC Microbiology
Company: ElevateBio
Location: Waltham, USA
Category:
