- 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.
Experience and Skill Requirements:
- Practical kn
- Computer literacy (including MS Word and Excel).
- Ability to work well with others.
- Effective communication skills.
- Good organizational skills.
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.
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.