Senior QC Specialist - Laboratory Manager II - 26006109

Senior QC Specialist - Laboratory Manager II Health Sciences Core Research Facilities - Pennsylvania-Pittsburgh - (26006109) Perform cell-based procedures that support product development, characterization, and release testing. Activities may include thawing and handling of primary human cells and cell therapy products, cell culture and expansion, cell selection and enrichment, activation, transduction, transfection, sample preparation, flow cytometry-based characterization, and functional assays. Participate in or lead analytical method qualification and validation activities. Develop study protocols, establish appropriate assay performance criteria, execute studies, analyze results, and prepare qualification or validation reports. Depending on the intended use of the assay, studies may include evaluation of accuracy, precision, specificity, sensitivity, linearity, range, robustness, system suitability, limits of detection or quantitation, and appropriate controls and reference materials. Support implementation and lifecycle management of analytical procedures in a regulated environment. Review analytical data for completeness, accuracy, traceability, and compliance with approved procedures, specifications, and acceptance criteria. Participate actively in the IMCPL Quality Management System. Responsibilities will include support for deviations, laboratory investigations, out-of-specification and out-of-trend results, corrective and preventive actions, change control, risk assessments, document control, equipment-related investigations, and continuous improvement activities. Author, review, and revise controlled documentation including Standard Operating Procedures, analytical methods, test procedures, batch records, worksheets, specifications, qualification and validation protocols, validation reports, technical reports, investigation reports, and training materials. Documentation must be clear, scientifically accurate, reproducible, and appropriate for a regulated cell and gene therapy environment. Train laboratory personnel in analytical procedures. Participate in analyst competency and proficiency programs, support qualification of staff for independent assay execution, and help maintain consistent analytical performance across the laboratory. Collaborate with Manufacturing, Quality Assurance, investigators, and product development teams to support analytical strategy, product characterization, specification development, manufacturing changes, View the full job description on the employer's website. Equal employment opportunity, including veterans and individuals with disabilities. PI287320341 / 11-9199.02 Compliance Managers