Lead QA Technician - Metrology

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

About the role

Join Thermo Fisher Scientific as a Lead QA Technician - Metrology and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.

Under the direct supervision of the Senior Manager, Quality Assurance, the Lead QA Technician - Metrology will assist Metrology Engineers and Quality Engineers, support the QC Labs by training, troubleshooting equipment, and updating quality work instructions.

Responsibilities

• Perform Metrology protocols (such as measurement uncertainty analysis for primary/working standards and process instrumentation) as defined by New Product Development (NPD), Metrology Engineering, and Quality Engineering.
• Execute Work Orders in support of manufacturing and NPD projects.
• Execute Work Orders in support of nonconformance and complaint investigations.
• Provide measurement systems/method investigational and corrective action support associated with non-conformances and complaints.
• Troubleshoot/repair lab equipment including coordinating supplier repair technician visits.
• Program CMM’s per guidance as per Inspection plans provided by Metrology and Quality Engineering.
• Provide technical consultation to others pertaining to measurement problems and assist technical project teams.
• Define problems, collect data, establish facts, and draw conclusions with complex metrology and calibration issues.
• Implement corrective and preventative action activities pertaining to measurement and calibration issues.
• Execute/support calibration procedures/calibration job plans and create/modify associated training materials.
• Develop and maintain Quality Work Instructions for lab inspection equipment and methods.
• Develop training plans and materials, conduct training, and maintain professional competency.
• Perform other responsibilities as needed.
• Support off-shifts as needed (24x7).

Requirements

• H.S. Diploma or GED; a two-year degree in technology or certification by ASQ is a plus.
• 2 years of experience working with CMM’s.
• Ability to understand and interpret technical procedures and specifications.
• Previous metrology experience in both manufacturing and R&D environments preferred.
• SAP or other ERP software proficiency is preferred.
• Experience in a regulated quality management system and ISO 17025/ANSI Z540.
• Great interdepartmental communication skills and documentation skills.
• Demonstrated ability to prioritize and accomplish goals while working across departments.
• Experience with physical processes and complex analytical equipment a plus.
• Strong attention to detail and analytical problem-solving skills.
• Experience supporting regulatory inspections and other audits.
• Knowledge of root cause analysis and quality improvement tools.
• Proficiency with Microsoft Office applications.

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.
• Laboratory setting.
• Exposure to loud noises (equipment/machinery).
• Office environment.
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Exposure to strong odors (chemical, lubricants, biological products, etc.).

Pay

The hourly pay range estimated for this position based in New York is $23.26–$34.89. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.