Quality Control

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

• Assist in set up and stocking of the QC microbiology laboratories to enable testing requirements in support of the facility.
• 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.
• Establish and perform sample management including receipt, inventory and aliquoting.
• 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.

• 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.

• BA or BS in Microbiology or other related science, preferably with Microbiology modules or coursework as part of the study program.

• 1-3 years of laboratory-based experience in a testing capacity.
• Knowledge of Microbiology techniques and technical experience, within a Microbiology Lab is preferred.
• Computer literacy (MS Word and Excel), good communication and organizational skills.
• Ability to work well independently and with others in a team.

Replimune is an equal opportunity employer.

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.

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.

Replimune now requires Covid vaccination disclosure for all US employees.

• Establish, write, revise and maintain procedures for QC testing.
• Set-up and maintain QC systems related to in-process, final drug product and stability sample testing.
• Perform QC testing of raw materials, in-process, water and product samples following Standard Operating Procedures (SOPs).
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Review testing data of other analysts. 
• Responsible for the protocol and report generation of assay transfers related to QC tests.
• Responsible for change control and deviation related to QC operations including assisting with OOS, OOT, and lab investigations.
• Assist with audits and regulatory inspections, as needed.
• Assist with the maintenance of QC laboratory and equipment.
• Assist with QC laboratory equipment validation.
• Oversee sampling and storage of QC samples and maintain inventory.
• Coordinate shipping and receipt of QC samples and other QC related material.
• Assist with training of others within department within the scope of knowledge and responsibilities.
• Interact within internal as well as across other functional group to communicate QC requirements. 
• Deputize for the Head of QC during periods of absence or when responsibilities have been delegated.

• Troubleshoot equipment and analytical methods.
• Manage technical studies performed with external companies with provision and review of reports.
• Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
• Other tasks as assigned.

• A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
• More than 5 years GLP / GMP experience in a relevant work environment.

• Practical kn

• Computer literacy (including MS Word and Excel).
• Ability to work well with others.
• Effective communication skills.
• Good organizational skills.

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.

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.

Replimune now requires Covid vaccination disclosure for all US employees.