Associate II, QC Microbiology

Responsibilities

• Perform routine microbial tests, analyze results, and record data in LIMS systems
• Perform routine entry and review into QMS systems including Veeva and Kneat
• Conduct routine cleanings of QC Microbiological equipment and document via CMMS systems
• Lead laboratory investigations associated with excursions and minor quality events
• Support investigational work associated with CAPAs, Change Controls, and OOSs
• Collaborate with other QC functions to ensure testing is completed within timelines
• Revise QC Microbiological Test Methods and SOPs
• Support QC Microbiological VALP’s and VALR’s

Requirements

• Bachelor’s degree in Biology, Chemistry, Microbiology, Engineering, or related field
• 2–4 years of experience in a GMP Quality Control microbiology lab setting
• Experience with QC Microbiological Test Methodologies (Environmental Monitoring, Endotoxin, Sterility, Bioburden, etc.)
• Experience with laboratory investigations and deviations
• Knowledge of GMPs, SOPs, GLP, and Quality System processes
• Ability to work a routine weekend schedule (10-hour shifts)
• Ability to aseptically gown and stand for 4 hours at a time

Preferred Qualifications

• Experience with Rapid Microbiological Techniques (Endosafe nexgen-MCS, BACT/ALERT 3D system)
• Experience in environmental monitoring or utilities monitoring
• Experience with MODA, Veeva, Kneat, SAP, and BMRAM

About the Company

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization through integrated technologies and manufacturing expertise.