Lead QA Technician â Batch Release
Lead QA Technician â Batch Release
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
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.)Job Description
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 140000 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.
Thermo 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.
Required Experience:
IC
Employment Type
Full-Time
