The Supervisor, QC Analysis will oversee the product release testing activities as part of the Reagent Manufacturing operation. The Supervisor oversees implementation of standards, methods, and procedures for inspecting, testing and evaluating the performance of Illumina products. The Reagent QC department operates 16 hours per day, 7 days per week, on two shifts, with occasional overtime work. The Supervisor will directly oversee the QC Analysts on this fast-paced operations team.
This role is a Sunday – Thursday position OR Tuesday - Saturday
Oversee routine and non-routine analytical assays to support release, characterization and stability testing of raw materials, intermediates and finished goods.
Schedule and coordinate resources to ensure QC activities are completed in a timely manner and within expected lead times.
Coordinate with technical Subject Matter Experts (SMEs) to troubleshoot product performance issues, support out of specification and non-conformance investigations, root cause analysis and CAPA activities.
Escalate trends in data to management.
Coordinate with Planning, Quality, Engineering, Warehouse/Logistics, and Manufacturing groups to deliver results.
Lead talent acquisition activities for new departmental hires, including interviewing, onboarding and training.
Lead performance management activities, including routine performance evaluations, annual performance reviews, and individual development plans, as needed.
Review completed records and documentation prior to release.
Act as backup to QC operators as needed.
Other duties may be assigned as determined by management.
5+ years of experience in the medical device or a related FDA-regulated industry
3+ years of experience in Quality Control or Quality Assurance, with 1+ year in a lead/supervisory capacity
Experience with analytical QC techniques such as: HPLC, GCMS, ICP-MS, UV/fluorescence spectroscopy, qPCR, biochemical (enzyme) assays, and LCMS
Strong verbal and written communication, interpersonal, and leadership skills
Strong organizational skills and attention to detail
Familiarity with Enterprise Resource Planning (ERP) systems, such as SAP, is preferred
Flexibility to be present during different shifts as needed
Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Bachelor’s degree in Organic Chemistry, Analytical Chemistry, Biochemistry or related scientific field is preferred.
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