Senior Quality Control Analyst

Replimune•Framingham, MA

22h•Onsite

About The Position

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Summary of job description: The Senior Analyst, 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 working in collaboration with cross functional laboratories. The Senior Analyst, QC 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.

Requirements

BA or BS in Chemistry/Biochemistry or other related science. Additional industrial experience acceptable as a substitute for degree level educational 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.

Responsibilities

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.