Supervisor, Quality Control
3 weeks ago
Job Description Job Description Description We are seeking an analytical, detail-oriented and collaborative individual to join our team as a Supervisor, Quality Control. This on-site role is responsible for the execution and oversight of the day-to-day activities associated with running our QC laboratory and is based in Lexington, MA. This position reports directly to the Director, Quality Control.Key Responsibilities Schedule daily QC tests in accordance with overall demand schedule.Perform review of data and ensure that all acceptance criteria are being met.Ensure staff are appropriately trained and following all relevant procedures.Ensure all QC laboratory equipment is operating properly and within specifications.Under the direction of the QC Director, write and update all relevant and necessary QC procedures.Under the direction of the QC Director, trend critical metrics.Oversee the daily work of QC Associates and ensure integrity and quality of their work.Under direction of the QC Director, work on special projects deemed to be business critical and / or critical to the operation of the QC organization.Work effectively cross-functionally to meet business goals.Under direction of the QC Director, manage process improvement efforts in QC to ensure product quality while maintaining efficiency and low COGS.Skills, Knowledge and Expertise BS or MS in related Life Science field, biology, chemistry or medical technology preferred. ASQ quality certification or equivalent a plus.7+ years of industry experience within Quality Control in a Medical Device / In Vitro Diagnostic manufacturing/production environment.21CFR Part 820, as well as a strong working knowledge regarding good laboratory and good documentation processes.Experience in laboratory techniques such as qPCR, UV/VIS, and buffer formulation is highly desirable.Understanding and awareness of cleanliness in a PCR laboratory to avoid contamination is required.Excellent skills in data analysis, statistical methods, statistical process control and sampling techniques required.Experience with QC test method design, optimization, and validation required.Experience in molecular diagnostics preferred.Excellent organizational, record keeping and communication skills (verbal and written).Ability to lead and manage a small lab-based QC team.#J-18808-Ljbffr
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