The Role:

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.

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

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

Skills & Competencies:

• 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.

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.