Associate I, QC Microbiology (Contract)

ElevateBio • Waltham, MA

16h • Onsite

About The Position

ElevateBio 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 Associate I, QC Microbiology is responsible for performing routine activities at our Waltham facility. This role 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. Activities of this position include but are not limited to, laboratory assays, environmental monitoring activities, data entry, and review.

Requirements

• Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with 0-2 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.
• Ability to follow and execute SOP’s.

Nice To Haves

• Knowledge of GMP, GLP, SOPs, and quality system processes a plus.
• Environmental monitoring as it applies to USP/ISO/EU Regulations
• Experience in Cell and Gene Therapy manufacturing environment is a plus.
• Experience with MODA, Veeva, Kneat, SAP, and BMRAM is a plus.

Responsibilities

• Perform routine environmental monitoring, utility monitoring, and safety testing of Cell Therapy drug products, ensuring that all work is carried out per cGMPs and applicable policies and procedures.
• Perform standard QC Microbiological assays. Bioburden, Endotoxin, Sterility, Growth Promotion, TOC/Conductivity, etc.
• Peer-reviewing assay results.
• Performing routine Data Entry/Review with LIMS systems.
• Perform routine QC Microbiology Environmental Monitoring and Utility Monitoring testing in Grade A/B/C and D cleanrooms.
• Perform routine Preventative Maintenance (PMs) for QCM Equipment.
• Support Quality Events including: Laboratory Investigations, Deviations, CAPA’s, Change Controls and associated Quality Actions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level