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Kincell Bio · 6 hours ago

Analyst III, Quality Control

Durham, NC

Full-time

Onsite

Mid Level

4+ years exp

Kincell Bio engineers cells into therapies and is a contract development and manufacturing organization focused on supporting innovative companies developing immune cell therapies. They are seeking a highly motivated QC Analyst III to contribute to the Quality Control team by leading quality control activities and ensuring compliance with cGMP and GDP practices.

BiopharmaBiotechnologyPharmaceutical

Responsibilities

Actively participate in fostering a positive, collaborative work culture

Author and revise standard operating procedures, test methods, protocols, and reports

Lead in execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations

Assist in the transfer of assays from the Analytical Development Lab to the QC Lab

Demonstrate proficiency in flow cytometric, automated cell counting, dPCR, qPCR, FTIR, ELISA-based, multiplex cytokine detection, pH, endotoxin, and cell-based assays

Ensure QC deliverables are met in a timely manner

Perform data analysis and review

Initiate and participate in laboratory investigations including deviations and out of specifications

Perform equipment calibrations

Execute method and equipment troubleshooting and optimization, as needed

Maintain documentation in accordance with GDP

Train and cross train QC personnel on standard operating lab procedures and test methods

Qualification

Quality ControlGMP environmentMolecular techniquesEukaryotic cell cultureStandard operating proceduresFDA regulationsMulti-taskingMicrosoft OfficeAttention to detailOrganizational skills