QC Laboratory ManagerQuality Engineer
Charlotte, NC - USA
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
We empower our teams with the resources support and opportunities needed to achieve their career goals while helping solve some of the worlds toughest challengesfrom protecting the environment and ensuring food safety to advancing life-saving therapies and treatments.
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.
- 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.
- Bachelors 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.
- 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.
- 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 differenceevery day.
Required Experience:
Manager
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more