QC Laboratory Manager/Quality Engineer

Thermo Fisher Scientific

Charlotte, North Carolina

JOB DETAILS
SKILLS
American Society for Quality (ASQ), Biology, Biotech and Pharmaceutical, Certified Quality Engineer (CQE), Change Control, Chemistry, Communication Skills, Continuous Improvement, Control Systems, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Satisfaction, Drug Manufacturing, Employee Orientation, Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Internal Audit, Laboratory, Laboratory Management, Laboratory Operations, Leadership, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Multitasking, Operational Improvement, Operations, Organizational Development/Management, Organizational Skills, People Management, Performance Management, Problem Solving Skills, Process Improvement, Project/Program Management, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Risk Management, Root Cause Analysis, SAP, Safety Standards, Supply Chain, Team Lead/Manager
LOCATION
Charlotte, North Carolina
POSTED
5 days ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Manager, QC Laboratory & Quality Engineer

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

We empower our teams with the resources, support, and opportunities needed to achieve their career goals while helping solve some of the world's toughest challenges—from protecting the environment and ensuring food safety to advancing life-saving therapies and treatments.

About the Role

Thermo Fisher Scientific is seeking a Manager, QC Laboratory & Quality Engineer to join our Quality Assurance team. This unique dual-role opportunity combines leadership of our Quality Control Laboratory with site-level Quality Engineering responsibilities, offering broad exposure across manufacturing, operations, engineering, and quality systems.

In this role, you will lead QC laboratory operations and personnel while driving quality improvement initiatives that strengthen compliance, reduce risk, improve operational performance, and enhance customer satisfaction. You will partner closely with Operations, Engineering, Manufacturing, Supply Chain, and Site Leadership to ensure the highest standards of product quality and regulatory compliance.

This is an excellent opportunity for a quality professional who enjoys balancing people leadership with hands-on quality engineering and continuous improvement activities.

Key Responsibilities

  • Lead daily operations of the QC Laboratory, including supervision, development, and performance management of laboratory personnel.
  • Ensure laboratory activities are conducted in compliance with applicable cGMP, ISO, regulatory, and company requirements.
  • Drive site quality engineering initiatives focused on risk reduction, process improvement, and quality system effectiveness.
  • Support and lead investigations, deviations, nonconformances, CAPAs, and root cause analyses.
  • Partner with cross-functional teams to improve manufacturing processes, product quality, and operational performance.
  • Support validation activities and quality risk management programs.
  • Participate in internal audits, customer audits, and regulatory inspections.
  • Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
  • Develop and deliver quality-related training and guidance to site personnel.

Required Qualifications

  • Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific discipline.
  • Minimum of 5 years of quality experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or related industry).
  • Minimum of 2 years of supervisory or team leadership experience.
  • Strong knowledge of cGMP regulations, quality systems, and applicable ISO standards.
  • Experience applying quality risk management principles and tools.
  • Demonstrated ability to lead initiatives, solve complex problems, and influence cross-functional teams.

Preferred Qualifications

  • ASQ certifications such as CQE, CQA, or equivalent.
  • Experience with batch record review, deviation management, CAPA, and change control systems.
  • Experience implementing quality improvements and continuous improvement initiatives.
  • Knowledge of validation principles and quality engineering methodologies.
  • Experience hosting regulatory inspections and customer audits.
  • Familiarity with electronic quality management systems such as TrackWise and SAP.
  • Strong project management, organizational, and communication skills.
  • Ability to manage multiple priorities in a fast-paced manufacturing environment.

Why Join Thermo Fisher Scientific?

  • Lead a high-impact QC laboratory team while expanding your quality engineering expertise.
  • Gain visibility and influence across multiple functions and site leadership.
  • Contribute directly to products and solutions that improve lives around the world.
  • Grow your career within a global organization committed to innovation, development, and scientific advancement.

Join us and help make a difference—every day.

About the Company

T

Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html