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Company:	Life Technologies (Thermo Fisher Scientific)
Industry:	Biotechnology / Pharma
Job Type:	Full Time
Country:	United States
State/Province:	Tennessee
City:	Lebanon
Post Date:	04/18/2024 05:26 PM
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. Excellent Benefits Package Review our company's Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 6% Tuition Reimbursement - eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities 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. Determine, organize, and apply necessary 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: High School Diploma required, Bachelor's Degree preferred Preferred Experience: 2+ years in manufacturing environment (cGMP) 2+ years in QA or QC Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21 CFR Part 11 Experience with Oracle, MasterControl, and TrackWise 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 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. Accessibility/Disability Access: Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Quality Specialist I

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