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Quality Analyst

Company: BioCentriq
Location: Newark
Posted on: August 4, 2022

Job Description:

DescriptionBioCentriq is a Biologics CDMO specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations and quality professionals, work with our clients to translate groundbreaking treatments into the clinic. The novel therapeutics we focus on require constant innovation and creative thinking for the clinical translation and subsequent GMP manufacturing to be successful. The BioCentriq state-of-the-art facility includes PD labs as well as clean room space to support clinical manufacturing projects of our clients. This role will be primarily located at our GMP facility in Newark. However, the project responsibilities will require periodic travel to our Pilot Plant in South Brunswick, NJ. We are currently expanding our multidisciplinary team, seeking a Quality Control Associate to support our Quality Control functions.Key Responsibilities include (but not limited to):Review/analyze testing protocols generated by contract testing laboratories for cell and gene therapy GMP production lots, including engineering and clinical material.Analyze incoming data and transfer information into internal systems (e.g. LIMS and QMS).Review deviations/investigations from outsourced laboratories.Manage logistics of shipping activities between contract manufacturing organization, investigators, and contract testing laboratories for both routine testing and investigational work.Perform optimization and troubleshooting experiments at BioCentriq laboratories.RequirementsBachelor's degree in technical discipline (Biology/Microbiology/or related field) with a minimum 2 years of experience in a GMP-related Quality Control position at a biotechnology, biologics, or pharmaceutical manufacturing facility.Experience with typical gene and cell therapy test methodologies (PCR, Flow Cytometry, ELISA/ELISpot, HPLC, and cell-based assays).Ability to communicate and work independently with scientific/technical personnel.Strong knowledge of GMP, SOPs, and quality system processes. Excellent organizational skills and Working knowledge of Office Suite.Experience performing laboratory investigations and supporting documentation.Preferred-Experience in cell and gene therapy manufacturing environment is preferred.Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.Experience in working with electronic QMS and MES systems

Keywords: BioCentriq, Newark , Quality Analyst, Professions , Newark, New Jersey

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