Quality Assurance Specialist I
Thermo Fisher Scientific

Work Schedule
First Shift (Days)

Environmental Conditions
Office

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.

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:

• 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)
• Review Lot records prior to release
• Release Manufacturing Lots
• Participate in self inspection activities as assigned
• Generate COA Templates
• 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; or a Bachelor degree with no experience

• 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 partnership 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
• Positon requires 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!

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