Thermo Fisher Scientific
Lead QA Technician - Batch Release
Thermo Fisher Scientific, Millersburg, Pennsylvania, United States, 17061
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionHours: Monday - Friday 6am - 2:30pmOvertime as neededLocation/Division Specific InformationThis position will be based at the Thermo Fisher Scientific site located in Millersburg, PA.How will you make an impact?Be part of a fast-growing manufacturing site that is committed to operational excellence in manufacturing and across the supply chain. This position will be necessary to enabling year-over-year double-digit growth by assisting through a vital role of Lead QA Technician for Batch Release.What will you do?Direct the daily workload to ensure batch review timelines are achieved while managing available resources and maintaining cGMP quality principles and standards including GDP and ALCOAManage and measure work by tracking and assigning responsibilities for tasks; set clear objectives and provide feedbackDevelop the Batch Release team by leading tasks and assignments and providing feedbackCollaborate with other site functions to drive processes and resolve issuesPerform Batch Record/Document ReviewReview & Revise SOPs/Quality DocumentationAssist/Drive the Tier processWork on Special Projects as assignedHow will you get here?Minimum Education Requirements:Minimum Required Education: HS Diploma/ GEDHigher education preferredExperience: 4+ years of manufacturing experience requiredAdvanced interpersonal skillsExperience working in a team environmentExperience in successfully crafting top quality work under ambitious timelinesProficient with Microsoft Office Suite (Word, Excel)Preferred Experience:Prior experience in a quality assurance/document release work environmentPrior quality management system experienceAbility to mentor, train, motivate and coachGenerating ERP System ReportsMedical Device IndustryISO 13485 / CFR820 and Clean Room ManufacturingLean 6 Sigma basicsExperience using M2MKnowledge, Skills, AbilitiesDetail OrientedProactiveKnowledge of Schedule Planning, Meeting Minutes, Action Items & Reminder NotificationsStrong collaboration skillsPositive attitude and solid communication skillsAbility to prioritize and manage multiple projects simultaneouslyAbility to influence without authorityAbility to develop credibility and positive professional relationships with subordinates, peers and upper managementAt Thermo Fisher Scientific, each one of our 140,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.