the qc specialist - stability candidate provides quality control analytical support of gmp manufacturing of cell therapy products at our us cell therapy facility located in princeton, nj.
this candidate will support in the entire range of quality control activities: assay performance, qualification/validation of assays, maintenance of laboratory equipment, and transfer of methods used in the manufacture of clinical and commercial products as it pertains to stability programs. responsible for compliance with regulations, procedures, and systems that relate to quality control. maintain data and follow cgmp regulations including writing deviations and other quality documentation. skill set includes (but is not limited to) working knowledge of basic cell culture, sample handling and flow cytometry.
our client is a growing biotech contract development and manufacturing organization (cdmo) with an internationally recognized tradition of quality and service. cell and gene therapy provides process development, process characterization, and gmp manufacturing services to industry leaders utilizing novel technologies to produce state-of-the-art vaccines and gene therapies.
the role
responsible for conducting stability testing in accordance with applicable procedures, standards, and gmp regulations in a safe work environment.
they may also be responsible for the support of process improvements, new technologies, automated quality systems, and the transfer of new methods.
conduct general analytical testing of stability samples submitted to the qc laboratories on an as-needed basis
review/approve qc laboratory data for validity and accuracy according to cgmp/cglp standards as needed
review statistical analysis, data trending, and reporting contribute to improvements or support quality & compliance and/or process improvement projects related to stability operations
responsible for initiating quality issues for oos / oot stability issues, engaging smes for statistical support of lab investigations and test plans, where required
complete and approve corrective and preventative actions (capa) as assigned, as well as independently execute and lead change control process
participate in internal / external audits and interact with health authorities during inspections and lead in discussions demonstrating a proficiency of lab systems, products, and technologies
performs general lab and equipment maintenance duties.
performs other duties as assigned.
the candidate
bachelor of science in life science degree is required. master of science degree is preferred.
5+ years’ experience within the biologic, biopharmaceutical, or regulated industry
advanced experience in scientific laboratory
advanced experience in cgmp environment
experience in quality control of cells from human tissue origin preferred.
experience as a lead/mentor to other analysts.
demonstrated knowledge in biological, cell-based assays including flow cytometry
should possess knowledge of how to execute methods/procedures and operate equipment
should perform tasks with strict adherence to cgxp principles
knowledge of basic and specialized lab equipment
able to identify breach of cgmp principles and provide suggested corrective actions
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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United States, Princeton ,New Jersey
2022-10-10
2022-11-09
2171288
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