Associate II, QC Microbiology

ElevateBio•Waltham, MA

17h•Onsite

About The Position

The QC Associate II will support a wider range of QC Microbiology activities in the cleanroom and laboratory at our BaseCamp 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 ElevateBio’s programs.

Requirements

Bachelor’s degree in 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 cross departmentally and within a team, as well as being able to complete tasks independently for routine tasks.
Excellent Organizational skills and attention to detail is 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 SOP’s in addition having an understanding of procedural structure and 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

Nice To Haves

Experience with Rapid Microbiological Techniques involved with Cell and Gene Therapy is a plus.
The Endosafe nexgen-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.

Responsibilities

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 VALP’s and VALR’s.
Assist in training.