Thermo Fisher
Lead QA Technician Batch Release
Thermo Fisher, Millersburg, Pennsylvania, United States, 17061
Lead QA Technician For Batch Release
Standard (Mon-Fri) Adherence 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.) Hours: Monday - Friday 6am - 2:30pm Overtime as needed Location/Division Specific Information This 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 ALCOA Manage and measure work by tracking and assigning responsibilities for tasks; set clear objectives and provide feedback Develop the Batch Release team by leading tasks and assignments and providing feedback Collaborate with other site functions to drive processes and resolve issues Perform Batch Record/Document Review Review & Revise SOPs/Quality Documentation Assist/Drive the Tier process Work on Special Projects as assigned How will you get here? Minimum Education Requirements: Minimum Required Education: HS Diploma/ GED Higher education preferred Experience: 4+ years of manufacturing experience required Advanced interpersonal skills Experience working in a team environment Experience in successfully crafting top quality work under ambitious timelines Proficient with Microsoft Office Suite (Word, Excel) Preferred Experience:
Prior experience in a quality assurance/document release work environment Prior quality management system experience Ability to mentor, train, motivate and coach Generating ERP System Reports Medical Device Industry ISO 13485 / CFR820 and Clean Room Manufacturing Lean 6 Sigma basics Experience using M2M Knowledge, Skills, Abilities
Detail Oriented Proactive Knowledge of Schedule Planning, Meeting Minutes, Action Items & Reminder Notifications Strong collaboration skills Positive attitude and solid communication skills Ability to prioritize and manage multiple projects simultaneously Ability to influence without authority Ability to develop credibility and positive professional relationships with subordinates, peers and upper management At Thermo Fisher Scientific, each one of our 140,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.
Standard (Mon-Fri) Adherence 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.) Hours: Monday - Friday 6am - 2:30pm Overtime as needed Location/Division Specific Information This 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 ALCOA Manage and measure work by tracking and assigning responsibilities for tasks; set clear objectives and provide feedback Develop the Batch Release team by leading tasks and assignments and providing feedback Collaborate with other site functions to drive processes and resolve issues Perform Batch Record/Document Review Review & Revise SOPs/Quality Documentation Assist/Drive the Tier process Work on Special Projects as assigned How will you get here? Minimum Education Requirements: Minimum Required Education: HS Diploma/ GED Higher education preferred Experience: 4+ years of manufacturing experience required Advanced interpersonal skills Experience working in a team environment Experience in successfully crafting top quality work under ambitious timelines Proficient with Microsoft Office Suite (Word, Excel) Preferred Experience:
Prior experience in a quality assurance/document release work environment Prior quality management system experience Ability to mentor, train, motivate and coach Generating ERP System Reports Medical Device Industry ISO 13485 / CFR820 and Clean Room Manufacturing Lean 6 Sigma basics Experience using M2M Knowledge, Skills, Abilities
Detail Oriented Proactive Knowledge of Schedule Planning, Meeting Minutes, Action Items & Reminder Notifications Strong collaboration skills Positive attitude and solid communication skills Ability to prioritize and manage multiple projects simultaneously Ability to influence without authority Ability to develop credibility and positive professional relationships with subordinates, peers and upper management At Thermo Fisher Scientific, each one of our 140,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.