Sr. Quality Control Analyst – Framingham, MA
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a brand-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. Working in collaboration with cross functional teams, the Senior Quality Control (QC) Analyst will assist in the setup of the QC laboratories and oversee the testing programs for raw materials used in the production process. The Senior Quality Control (QC) Analyst will be responsible for performing the routine and non-routine QC sampling and testing of raw materials following Standard Operating Procedures (SOPs) and established test methods.
This position is based at Replimune’s Framingham facility, and will report to the Director of Quality Control (reporting to the VP of Operations in the interim).
The responsibilities of the Senior QC Analyst include the following:
- Assist with set up and stocking of the QC laboratories and sampling areas.
- Manage the raw materials sampling and testing program to ensure materials are released to meet the production schedule.
- Establish and perform internal methods for identity testing of raw materials.
- Coordinate shipment of samples to external testing laboratories and review of testing/data reports.
- Establishes and manages a qualification program for raw materials to confirm to Pharmacopeia requirements
- Perform QC testing of in-process, final product, and raw material samples according to Standard Operating Procedures. Test methods may include but are not limited to; pH, conductivity, osmolality, plaque assay, ELISA’s, gel electrophoresis, spectroscopy, and visual appearance.
- Perform water sampling and associated water testing (basic chemical analysis to include USP tests for TOC, pH, conductivity, etc.).
- Represent QC at inter-departmental meetings and interact with external vendors.
- Train other analysts within the department within scope of knowledge.
- Review testing data and records of other QC Analysts, as applicable.
- Write or revise SOPs, protocols and technical reports.
- Participate in QC equipment validation, method transfers and qualifications.
- Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
- Troubleshoot equipment / analytical testing methods and apply continuous improvement
- Raise change controls and deviations related to QC and assist with non-conformance investigations.
- Assist with internal and regulatory agency audits / inspections.
- Ensure training is kept in GMP compliant state.
- BA or BS in Chemistry/Biochemistry or other related science.
Experience and Skill Requirements:
- Three to five years of laboratory-based experience in a testing capacity, preferably GMP.
- Excellent analytical skills and technical experience is a must, preferentially with previous experience in product and raw materials testing.
- Thorough understanding of industry testing requirements for GMP raw materials.
- Computer literacy (including MS Word and Excel), good communication and organizational skills.
- Ability to work independently and with others in a team.
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.