QC Associate III- Cell Therapy Flow Cytometry
Posted on: 6 Jul 2021
Bothell, WA
Job Description
PURPOSE AND SCOPE OF POSITION:
The primary focus of the Quality Control Associate III role will be to support product lot release and in-process testing within a cGMP environment. Additionally, this role will provide technical support and troubleshooting for the support of lot release, in-process, and stability testing.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education:
BS in a scientific discipline.
Experience
6+ years of analytical QC testing within a regulated environment, or equivalent combination of education and experience.
Experience working in a regulated (GxP) environment and familiarity with flow cytometry preferred.
Demonstrated success working in a high-performing, business results-driven environment.
Knowledge, Skills, and Abilities
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects without supervision.
Strong analytical and communication skills.
Computer proficiency as well as strong scientific and organizational skills.
Experience working in a GMP environment.
Demonstrated success working in a high-performing, business results-driven environment.
Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
Ability to maintain flexible intellect and adjust to a dynamic work environment.
Detail-oriented with strong time-management skills.
DUTIES AND RESPONSIBILITIES:
Key Responsibilities
Perform or support cGMP lot release, in-process, and stability testing using flow cytometry.
Ensure timely completion of testing and tasks as assigned.
Perform assay and form review.
Lead assay transfer and method validation of by representing site QC in cross-site validation protocols and providing data to support final reports.
Participate in cross-functional training.
Author and revise test methods, SOPs, raw material specification, and/or sample plans as appropriate.
Identify and facilitate continuous improvements.
Execute technical transfer and validation protocols for QC assays.
Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.
Assist in the implementation of new assay methodologies and the associated instrumentation.
Identify and support initiation and completion of Deviations, CAPAs and Laboratory Investigations.
Act as a lead in small to medium scale projects.
Act as owners for Deviation, CAPA, Laboratory Investigations, and Change Controls records.
Train other on QC processes and procedures
Celgene
Summit, NJ
Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.
The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.
The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.
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IndustryBiopharmaceuticals
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No. of Employees8, 852
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Website
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Jobs Posted1399
