Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Rochester, New York, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 2 years of experience working with CMM’s. Ability to understand and interpret technical procedures and specifications Prefer previous metrology experiences in both manufacturing and R&D environments. SAP or other ERP software proficiency is preferred. Support off-shifts as needed (24x7). KNOWLEDGE, SKILLS, ABILITIES Experience in a regulated quality management system and ISO 17025/ANSI Z540. Great interdepartmental communication skills and documentation skills are required. Demonstrated ability to prioritize and accomplish goals while working across departments is essential. 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
- Education
- H.S. Diploma or GED; a two year degree in technology or certification by ASQ is a plus.
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Role Summary
The Lead QA Technician - Metrology supports quality oversight and regulatory compliance for pharmaceutical manufacturing operations. The role assists Metrology and Quality Engineers and supports QC labs through equipment troubleshooting, training, and quality work-instruction updates.
What You'll Do
- Perform metrology protocols, including measurement uncertainty analysis for standards and process instrumentation.
- Execute work orders supporting manufacturing, new product development, nonconformance, and complaint investigations.
- Support measurement-system and method investigations and corrective actions related to nonconformances and complaints.
- Troubleshoot and repair lab equipment, including coordinating supplier repair visits, and program CMMs according to inspection plans.
- Support calibration procedures and job plans, create or modify training materials, and develop and maintain quality work instructions.
- Develop training plans and materials, conduct training, and maintain professional competency.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Minimum qualifications include a high school diploma or GED, 2 years of experience working with CMMs, and the ability to understand and interpret technical procedures and specifications. The posting also identifies experience in a regulated quality management system and ISO 17025/ANSI Z540, interdepartmental communication and documentation skills, prioritization across departments, attention to detail, analytical problem-solving, regulatory inspection and audit support, root cause analysis and quality improvement tools, and Microsoft Office proficiency.
Required
- Experience in a regulated quality management system and ISO 17025/ANSI Z540.
- Great interdepartmental communication skills and documentation skills are required.
- Demonstrated ability to prioritize and accomplish goals while working across departments is essential.
- 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.
Preferred
- A two year degree in technology or certification by ASQ is a plus.
- Prefer previous metrology experiences in both manufacturing and R&D environments.
- SAP or other ERP software proficiency is preferred.
- Experience with physical processes and complex analytical equipment a plus.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)Job Description
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. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
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 be responsible for assisting Metrology Engineers and Quality Engineers. The Lead QA Technician - Metrology will also help to support the QC Labs by training, troubleshooting equipment, and updating quality work instructions.
KEY REQUIREMENTS:
- 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.
- Programming CMM’s per guidance as per Inspection plans provided by Metrology and Quality Engineering
- Provides technical consultation to others pertaining to measurement problems and assists technical project teams.
- Ability to 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.
MINIMUM 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
- Prefer previous metrology experiences in both manufacturing and R&D environments.
- SAP or other ERP software proficiency is preferred.
- Support off-shifts as needed (24x7).
KNOWLEDGE, SKILLS, ABILITIES
- Experience in a regulated quality management system and ISO 17025/ANSI Z540.
- Great interdepartmental communication skills and documentation skills are required.
- Demonstrated ability to prioritize and accomplish goals while working across departments is essential.
- 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
Compensation and Benefits
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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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 our 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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.