Quality Specialist III

Thermo Fisher Scientific • Sunnyvale, CA

4d • Onsite

About The Position

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. Discover Impactful Work Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will support regulatory compliance and drive continuous improvement of quality systems that enable our customers to make the world healthier, cleaner, and safer. You will collaborate with cross-functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actions while fostering a culture of quality excellence throughout the organization.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology or related technical field with 5+ years of experience in quality assurance/quality control or Advanced degree with 3+ years of relevant experience
• Experience in regulated industries (pharmaceutical, medical device, or biotech preferred)
• Experience with quality management systems (TrackWise, Document Control Systems), CAPA processes, deviation management, and change control
• Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation
• Experience conducting and hosting internal/external audits and regulatory inspections
• Proficiency in statistical analysis, data trending, and quality metrics reporting
• Must be legally authorized to work in the United States without sponsorship now or in the future
• Must be able to pass a comprehensive background check and drug screen

Nice To Haves

• Project management experience preferred
• Ability to work in manufacturing environments with appropriate PPE as needed

Responsibilities

• Support and maintain compliance with GMP/GxP, ISO, and regulatory requirements
• Investigate quality issues and lead root cause analysis efforts
• Manage and support CAPA processes
• Manage and support Deviations and nonconformances
• Manage and support Change control activities
• Conduct and support internal and external audits and regulatory inspections
• Author and review quality documentation (SOPs, investigation reports, etc.)
• Perform data analysis, trending, and reporting of quality metrics
• Collaborate with cross-functional teams to drive corrective and preventive actions
• Support continuous improvement initiatives and quality system enhancements

Benefits

• 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
• Short- and long-term disability
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level