Replimune, Inc.

Sr. QC Analyst Microbiology

Job Locations US-MA-Framingham
ID
2022-1189
Category
Quality Control
Position Type
Regular Full-Time

Overview

Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories.  The Senior Quality Control (QC) Microbiology Analyst will be responsible for the performance of the routine QC sampling and testing within the function of the Quality Control (QC) Microbiology Laboratory. Additionally, the Senior QC Microbiology Analyst will assist in setting up and maintaining the QC Microbiology laboratories, scheduling the routine QC Microbiology testing and oversee the performance of non-routine / investigational testing performed within the Microbiology Laboratories. It is expected that the Senior QC Microbiology Analyst maintains GMP compliance in the QC Microbiology laboratory.

 

This position is based at the Replimune Framingham facility

Responsibilities

The responsibilities of the Senior QC Microbiology Analyst include, but are not limited, to the following:

  • Setting up and maintaining of the QC microbiology laboratories and systems needed to enable testing requirements in support of the facility.
  • Assist in scheduling and oversight of environmental monitoring testing performed in QC Microbiology laboratories.
  • Execute the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
  • Perform routine QC Microbiology sampling and testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications.
  • Perform water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.).
  • Sampling and testing of gas supplies to manufacturing suites.
  • Trend environmental monitoring data and compile trend reports.
  • Write and revise SOPs, protocols and technical reports as necessary.
  • Coordinate shipment of samples to contract testing laboratories and review of testing data reports.
  • Review testing data of other QC Analysts, as applicable.
  • Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory and ordering of supplies, etc.
  • Maintain QC Microbiology related systems in compliance with industry standards.

Other Responsibilities:

  • Act as deputy for the QC Manager with regards to QC Microbiology matters (in absence of QC Manager, Microbiology).
  • Represent QC at inter-departmental meetings and interact with external vendors as necessary.
  • Raise change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.
  • Assist in regulatory audits/inspections, as needed.
  • Troubleshooting of equipment and QC methods.
  • Train other QC Analysts within scope of knowledge.

Qualifications

Experience and Skill Requirements:
• 3-5 years of Microbiology laboratory-based experience in a QC testing capacity.
• Excellent microbiological skills and technical experience is a must.
• Thorough understanding of industry testing requirements for QC Microbiology and experience of cGMP.
• Computer literacy (MS Word and Excel), good communication and organizational skills.
• Ability to work well independently and with others in a team.
Educational Requirements:
• BA or BS in Microbiology or other related science, preferably with Microbiology modules or coursework as part of the study program.

 

*Please note: Candidates must be local or open to relocating as remote is not an option for some roles.  

Woburn Location: Local candidates are expected to be on-site 2 days per week. Non-local candidates open to 10-25% travel to Woburn office

Framingham Location: Please Note for Framingham roles 5 day onsite expectation

Replimune is an equal opportunity employer.

Replimune now requires COVID vaccination disclosure for all US employees.

 

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