Work ScheduleFirst Shift (Days)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowedJob DescriptionWhen your part of the team, you’ll do important work, like helping customers with finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. As a Manufacturing Quality Leader you’ll help ensure quality products are delivered to our customers safely and on time. You will partner with the production team to tackle problems, improve processes and ensure that our quality management system (QMS) continues to mature with changing customer and regulatory expectations!How will you make an impact?Leading the Quality Control Technicians inspecting final productSingle Use Systems to be used by our customers to manufacture lifesaving drugs or biotherapies. These final products will be used by the highly regulated biopharmaceutical industry and must be delivered on time with the highest quality. Your oversight of the QC team who conducts the in-process and final inspection of these crucial products is a criticalcomponent of the sites QMS and the overall integrity of the final product. Furthermore, it is a crucial element to the site's ability to deliver products on time efficiently and profitably.Position Summary:Support advancement of proactive quality initiatives and projects such as Design for Manufacturability, QC Optimization, and Defects Review Board. Act as a delegate toSupervise and develop QCTS. This positionis in a 24hr production facility and may have responsibilities across multiple shifts. This position requires asuccessful candidate to Supervise, Train, Mentor, Identify and Solve problems,and support QC teammanagement.Responsibilities:Assign QCTs to various Value Streams as the need arises and according to production/inspection demand.Perform trending of in-process QC dataSupport advancement of proactive quality initiatives and projects such as Design for Manufacturability, QC Optimization, and Defects Review BoardProblem Solving – support customer complaints / atypical event managementDocument Management – draft, edit review standard operating procedures (SOP’s) and testing protocolsTesting – establish, optimize andexecute test methods and test protocolsContinuous Improvement – apply practical process improvement (PPI) methodology to improve in the areas of quality, safety and efficiencyNew Product and Process development – work closely with engineering to implement new products and processesAuditing to site QMS, ISO 13485 and FDA 21 CFR 820 standardsRequired Qualifications:2-year associate degree2+ year(s) experience in supervising othersExcellent writing and interpersonal skillsAbility to interface well with all other working levelsPreferred Qualifications:Experience in Manufacturing EnvironmentTechnical Writing ExperienceWorking knowledge of Root Cause Countermeasures processKnowledge of ISO13485Knowledge of FDA 21CFR820Ability to read and understand CAD drawingsUnderstanding of MetrologyExperience with cGMP manufacturingLean Six Sigma UnderstandingBachelor’s degree from an accredited higher learning programwith majors in science or business-related field.Each one of our 125,000 outstanding minds has a unique story to tell. Join us and chip in to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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