Engineer I, QA

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South San Francisco, CA
58K-87K Annually
3-5 Years Experience
Biotech
The Role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

We have industry leading Genetic Science research and development and manufactuing facilities providing solutions to take crucial product from NPI to the market.

Provide Quality oversight for processes and projects, performs compliance assessments, develop use the use of AI within Quality, perform internal audits and ensures adherence to current regulations.

  • Performs daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and ISO 9001 and 13485 requirements.
  • Release "Quarantined" product into good upon the receipt of documentation from QC and Manufacturing
  • Verifies the system is identifying "released" product accurately.
  • Review final QC Batch Release reports to ensure accuracy
  • Create Certificates of Assurance for products managed by the site
  • Manage and administer the site's equipment calibration process
  • Communicate and maintain the Quality Management System
  • Conducting daily review of key performance quality metrics
  • Provides internal and external product quality support
  • Identify and develop the use of AI to support Quality initiatives
  • Performs quality internal audits and resolve identified non-conformities
  • Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
  • Aids in identification of continuous improvement opportunities
  • Participates in practical process improvement (PPI) initiatives

Compensation and Benefits

The salary range estimated for this position based in California is $58,100.00-$87,125.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

The Company
100,000 Employees
Hybrid Workplace

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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