Quality Specialist I

ThermoFisher Scientific

Lebanon, TN

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JOB DETAILS

SKILLS

Analysis Skills, Cancer, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Detail Oriented, Document Control, Documentation, FDA (Food and Drug Administration), Food Safety, ISO (International Organization for Standardization), Industry Standards, Interpersonal Skills, Manufacturing, Microsoft Excel, Microsoft PowerPoint, Microsoft Product Family, Microsoft Word, Oracle, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Producer Price Index (PPI), Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Team Player, Technical Support, Technical Writing, Writing Skills

LOCATION

Lebanon, TN

POSTED

4 days ago

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

Quality Assurance Specialist I Job Description June 2026

About Thermo Fisher Scientific:

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.

Location/Division Specific Information:

Now is an exciting time to join our Nashville (Lebanon, TN/SUT) Quality team, a team dedicated to ensuring our customers receive the products they need to achieve their scientific goals – quickly, reliably, and safely. If you believe in working the right way for the right reason join our growing team today!

Discover Impactful Work:

The Quality Specialist I will assist and support the organization in meeting Quality objectives and assure compliance with industry standards. Organize, and apply vital resources to meet identified Quality Requirements. Ensure Corporate, Regulatory, Quality requirements are met. Ensure that customer expectations are met or exceeded.

A day in the Life:

+ Review Batch Records prior to release + Release Manufacturing Lots + Generate COA Templates + Generate Finished Product Labels + Maintain imaging program and process for Quality Documents + Log TrackWise records when needed/applicable + Participate & Maintain Investigative Processes (PNs, Deviations, CAPA)Participate in self inspection activities as assigned + Participate in other QMS efforts such as CAPA, Non-conformances, document control, training, supplier quality, etc. + Participate in PPI (continuous improvement) events

Quality Responsibilities:

+ Observes all departmental and Quality System procedures and work instructions. + Supports Thermo Fisher Scientific’s commitment for continuous improvement by documenting process improvement opportunities thorough the Quality System.

Education and Experience:

+ 3 years related experience with HS Diploma (preferably in a cGMP environment); 2 years related experience with Associates Degree; + Quality experience in a Quality Assurance arena highly preferred + Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21 CFR Part 11 preferred + Experience with Oracle, MasterControl, and TrackWise preferred

Minimum Requirements/Qualifications:

+ Ability to work independently with little direct supervision + Proficient with Microsoft tools; Word, Excel, Power Point, Teams + Organization Skills + Attention to detail + Problem solving skills + Strong teamwork and collaboration skills + Organized and clear technical writing: ability to communicate technical and analytical language in written prose executive summaries and conclusions + Demonstrate knowledge of Quality management System tools, continuous improvement methodologies, in-depth understanding of products and processes + Excellent interpersonal, organization, and influencing skill + Excellent communication, written and presentation skills + Must be comfortable working primarily at a desk, in an office setting + This position requires following cGMP (Current Good Manufacturing Practices) and working in a fast-paced team environment

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com 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. 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.

About the Company

ThermoFisher 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

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