Work Schedule First Shift (Days) Environmental Conditions: Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Location/Division Specific Information This role is based at our Detroit, Michigan campus, supporting our Biologicals and Chemicals Division. The Detroit Site maintains ISO 13485 Quality Management System (QMS) certification, manufacturing peptones and other fine chemicals used in bioproduction and culture media.
Discover Impactful Work The Quality Specialist II will have various responsibilities within Quality Assurance to support product release activities, ensuring on-time delivery to customers as well as initiatives for maintaining compliance to the QMS.
A Day in the Life:
Keys to Success Education A Bachelors Degree is required. A science major preferred.
Experience Minimum of 2 years experience in a Quality Assurance function in an ISO 13485 environment. Familiarity with the life sciences industry is desired.
Record review and/or auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred but not required.
Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages.
Knowledge, Skills, Abilities Strong critical thinking skills, with a close attention to detail and history of good judgment.
Proven ability to prioritize work according to urgency and impact, with good time management skills.
Driven and resourceful, with minimal to moderate direction required.
Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfortable with learning and using new software programs.
Strong technical writing skills.
Proven ability to work in a team and matrixed 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.
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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.