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Form of workJob Description
Summary: Seeking a QC Analyst with experience in quality testing related to manufacturing of Cell & Gene Therapy products in a controlled cGMP environment.
Requirements:
3-5 years of experience in a similar role
Knowledge/Experience with Flow Cytometry, qPCR, ddPCR, ELISA, Cell Viability measurement
Experience/Familiarity with FDA, ICH, USP and GMP guidelines pertaining to a QC lab
Proficiency/Experience with Gene/Cell therapy products for clinical production
Experience in supporting lab investigations, deviations, CAPAs and change controls
Expertise/Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based product
Responsibilities:
Completion of in-process, release and stability Quality testing related to manufacturing of Cell & Gene Therapy products
Collaboratively engage with Process Development/Analytical Development/ Manufacturing Science & Technology team, Quality and Operations for analytical testing transfer to cGMP facility
Analytically test raw material/reagent samples submitted to the Quality labs
Perform review of laboratory data
Create, review and approve relevant QC documents such as Standard Operating Procedures, Work Instructions, Analytical Testing Methods, and Forms
Perform tasks within a CAPA, Deviation or other quality-driven projects
-Provide input on timelines by participating in meetings about potential compliance issues and other related QC activities.
Pay Details: $25.00 to $30.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
