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Bio Quality Control Incoming Material Associate

Bristol Myers Squibb

Overview Biologics Quality Control Incoming Materials Associate — Position Summary: The Biologics QC Incoming Materials Analyst is responsible for the receipt, testing, and release of raw materials used in biologics manufacturing. This role supports laboratory operations and contributes to the Smart-QC initiative aimed at enhancing digital and operational efficiency across QC functions. Responsibilities Receive and process incoming raw material samples in accordance with SOPs and regulatory requirements. Perform analytical testing (e.g., identity, purity, and quality assessments) using validated methods. Review Certificates of Analysis (CoA) and Certificates of Testing (CoT) from Contract Testing Labs (CTLs) and ensure accurate data entry into LIMS. Support reduced testing programs and vendor qualification processes in collaboration with Supplier Quality. Performs routine testing and data review of Incoming Materials in a cGMP compliant environment. Performs routine assays such as Osmolality, Nitrate, pH, Solubility, FTIR, Heavy Metal testing and more. Performs send outs of Raw Materials that are testing at contract testing labs. May write and revise SOPs for managerial review and approval. Experience in analytical test methods such as Osmolality, Nitrate, pH, Solubility highly preferred. Knowledge of lab software applications (e.g., LIMS, ELN (LES/SmartLab), Empower) preferred. Excellent manual dexterity including proficiency in aseptic techniques desired. High attention to detail with strong general laboratory and good organizational skills. Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices. Demonstrates problem solving and analytical thinking skills. Qualifications & Experience Knowledge of science generally attained through studies resulting in a BS degree, preferably in Chemistry, Molecular Biology, or related discipline. A minimum of 2-4 years of experience in a Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab. Compensation & Benefits The compensation overview and benefits details described in the posting may vary by location and are subject to eligibility and plan terms. For more information, visit the careers site. #J-18808-Ljbffr Bristol Myers Squibb

Vacancy posted more than 2 months ago

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