Quality Specialist III

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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.

Location

This is a fully onsite role in Sunnyvale CA with weekly travel to our San Jose CA site. Relocation assistance is not provided.

A Day in the Life

• 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
  • Deviations and nonconformances
  • 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

Keys to Success

Education

Bachelors 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:

• 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
• Project management experience preferred

Knowledge Skills Abilities

• Strong knowledge of GMP/GxP regulations ISO standards (9001/13485) and other relevant quality system requirements
• Knowledge of risk assessment methodologies and continuous improvement tools
• Strong technical writing skills for authoring SOPs investigation reports and other quality documentation
• Advanced problem-solving abilities and attention to detail
• Excellent verbal and written communication skills
• Strong interpersonal skills with ability to collaborate across functions and levels
• Ability to work in manufacturing environments with appropriate PPE as needed
• Ability to work independently and guide cross-functional teams
• May require up to 25% travel

Other:

• 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

Compensation and Benefits

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: Experience:

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