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Quality Specialist-Experience With Flow Cytometer

Company: Actalent
Location: Arcadia
Posted on: September 17, 2022

Job Description:

R&D/Analytical Science
Front-line facing the client
Will be interfacing with the method transfer, reviewing, etc
Designing QC
Qualify/Validating Testing
Routine Testing; generating Data, NC-CAPA, OS Investigation

Leads implementation of new methods transferred by the clients and Analytical Development lab.
Originates and revises QC related procedures and analytical methods.
Leads and supports invalid assay, exceptions, and lab investigations.
Ensures compliance to all quality requirements to meet audit standards and regulatory compliance.
Maintains lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.
Assists in creating training materials and trains staff on methods and related SOPs
Collaborates with other Functional Areas (Analytical Development, Materials Sciences and Technology, Process Development and Manufacturing) for methods transfer, qualifications, validation, sample plan development and timely testing of samples.
Executes assays to assess various cell and gene therapy products using flow cytometer, PCR, and cell-based assays.
Become SME on laboratory procedures including ddPCR, qPCR, ELISA, and flow.
Implements, and qualifies current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.
Analyzes and summarizes data into reports and certificate of analysis with attention to details.
Participates in risk assessment, HAZOP and FMEA.
Reviews and assesses proposed corrective and preventive actions and improvements identified through investigations and audits.
Performs sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.
Collaborates with external clients, contractors, and vendors.
Participates with internal audits and external audits and leads in authoring responses and implementation of actions.
pcr, elisa, assay
Top Skills Details:
Additional Skills & Qualifications:
Bachelor's degree in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required.
Minimum of 4+ years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLP (QC Specialist; Scientist; Supervisor/Manager Level)
Executes assays to assess various cell and gene therapy products using flow cytometer, PCR, and cell-based assays.
Become SME on laboratory procedures including ddPCR, qPCR, ELISA, and flow cytometry.
Hands on experience - they will be setting up the lab
PCR Experience; ELISA; Flow Cytometry Experience
NEED GMP experience regulations; time management; good documentation; troubleshoot
Experience Level:
Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Arcadia , Quality Specialist-Experience With Flow Cytometer, Other , Arcadia, California

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