Associate I, QC Microbiology (Contract)

The Role:

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.

Here’s What You’ll Do:

• 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.

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.
• Skills & Competencies:
  • 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.
• Work Environment & Physical Demands:
  • 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

The budgeted range for this position is $33/hour - $48/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.