Scientist I, Quality Control
$112,500–$112,500 year
On-siteFramingham, Massachusetts, United States
Job Summary
Establish, revise, and maintain procedures for QC analytical testing while performing tests on raw materials, in-process, and final drug product samples per SOPs. Review testing data from other analysts, manage change control, deviations, and CAPA investigations including OOS and OOT events, and assist with equipment validation and audits. Coordinate sample shipping to contract labs, oversee sampling and storage, and train junior staff. Maintain GMP compliance and cGMP documentation across the laboratory. This role supports Replimune's mission to revolutionize cancer treatment through rigorous quality control in our Framingham facility.
Required Qualifications
- BA or BS in analytical chemistry or other related science
- 5+ years of experience working in GMP/GLP environment or similar set up
- Knowledge of Analytical techniques and technical experience, within a Analytical Lab
- Computer literacy (MS Word and Excel)
- Good communication and organizational skills
- Ability to work well independently and with others in a team
- Good organizational skills
- This position is based in our Framingham location
- typically has a 5-day on-site expectation
Desired Qualifications
- preferably with chemistry or coursework as part of the study program
- Knowledge of Analytical techniques and technical experience, within a Analytical Lab is preferred
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