Quality Assurance Specialist III

Job description

When you join Thermo Fisher Scientific, 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 and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 90,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

US - Pleasanton, California

How will you make an impact?

The QA Specialist will help maintain and grow the sites quality management system (QMS) in support of our Genetic Sciences business. They will ensure compliance to all governing procedures, standards and regulations. They will use common industry tools and techniques for handling deviations, CAPA, non-conforming material, and continuous improvement.

What will you do?

• Partner with operations, engineering and technical teams to support quality and business objectives
• Review and process CAPA in timely manner including driving investigations and root cause analysis
• Facilitate and provide input to proposed changes to manufacturing processes, materials and procedures, including risk assessment
• Help with product release activities (including batch record review) and assist with audits
• Support Validations for equipment, processes and software
• Write, review and revise Standard Operating Procedures (SOPs)
• Drive continuous improvement using quality data, metrics and Practical Process Improvement (PPI) tools.
• Assist with other projects or tasks within the Quality Assurance department

How will you get here?

Education

• Bachelor's degree in life sciences, chemistry, biotechnology or related sciences.

Experience

• 4 - 6+ years proven experience in an FDA regulated environment (drugs, biologics, medical devices or related products) including in a Quality Assurance or Quality Engineer role.
• Experience with Quality tools and methodologies including investigation, root cause analysis, and FMEA
• Laboratory experience with qPCR technologies a plus

Knowledge, Skills, Abilities

• Excellent understanding of regulations and standards (21CFR820, ISO13485, 14971 and IVDR)
• Strong interpersonal, written and verbal communication, with the ability to work collaboratively to accomplish objectives
• Possesses strong organizational skills to manage and prioritize multiple tasks while meeting delivery dates
• Excellent judgement and creative problem-solving skills
• Energetic, flexible, collaborative and proactive
• Work independently and in team to achieve results
• Ability to manage issues through to resolution.

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today!

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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