Quality Control Specialist (QSAT) - Non Laboratory
Quality Control Specialist
We're looking for a Quality Control Specialist who has a strong release testing background. Join our mission to improve the human condition through systems, consumables and services for researchers. This role is a non-laboratory position that will lead implementation of QC methods used for release testing of autologous stem cell drug products. Our ideal goal oriented and energetic Quality Control candidate will be a great addition to the Quality Sciences and Analytical Technology team.
About the Role:
- Conduct method implementation activities across a diverse CxO network and as part of technical transfers / manufacturing process improvements for cell therapies.
- Own deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results obtained during technical transfers / process improvements across the CxO network
- Conduct QC operational efforts required for technical transfers / process improvements including QC documentation (e.g. sampling plans), shipment, submitting legal contracts and owning POs
- Write and review protocols, reports and technical assessments
- Perform review and statistical analysis of data generated during method lifecycle activities such as method validation, robustness studies and method comparability studies
- Carry out gap assessments of analytical methods used throughout the CxO network to facilitate method harmonization against industry guidance documents for analytical/ compendial methods
- BS/BA in Biology (or related discipline) with 3-5 years of experience in a biotechnology discipline
- Experience in GMP/GxP environment as well as an Analytical Development, Manufacturing Sciences or Quality Control unit is required
- Experience with QC activities required for technical transfers or manufacturing process improvements: release testing, method implementation, quality system management
- Proven track record and analytical experience performing mammalian cell culture, flow cytometry, liquid chromatography or mass spectrometry is preferred
- Experience with Microsoft Word, Excel, PowerPoint and a statistical software (i.e. JMP, Prism)
- Strong initiative and scientific mindset that is motivated by analytical and operational challenges
If you or someone you know in your network is interested in this position, then please send an updated resume to the attention of N.Silvera (AT SIGN) realstaffing.com and her team at Real Staffing Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.