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Sr. QC Analyst Microbiology – Framingham, MA

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.

 

Key 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.

 

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.

 



EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.


Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.