Quality Specialist I

Thermo Fisher Scientific•Lebanon, TN

6d•Onsite

About The Position

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.

Requirements

3 years related experience with HS Diploma (preferably in a cGMP environment)
2 years related experience with Associates Degree
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

Nice To Haves

Quality experience in a Quality Assurance arena highly preferred
Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21CFR Part 11 preferred
Experience with Oracle, MasterControl, and TrackWise preferred

Responsibilities

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
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.