Quality Specialist II

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Job description

Job Title: QA Specialist II
Requisition number: 182762BR

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.

US - Pleasanton, California

Discover Impactful Work: The QA Specialist will help maintain and grow the sites quality management system (QMS) in support of our Genetic Sciences business. Their focus will be on ensuring finished products are released in a timely manner and in compliance to applicable procedures, standards and regulations. They will ensure products meet all specifications and that device history records (DHR) are complete and accurate.

What will you do?

• Review batch records for medical device products in accordance with cGMP, including good documentation practices (GDP)
• Ensure traceability to materials and equipment
• Generate Certificate of Analysis for finished good materials
• Identify and record any deviations related to a product's release; help process and review deviations as needed.
• Complete product release steps in our business systems including SAP and E1
• Provide training to personnel on GDP, DHF and product release procedures
• Supports internal and external audits, including audit of batch records and release activities for RUO products.
• Write, review and revise Standard Operating Procedures (SOPs)
• Identify and implement improvements using quality data, metrics and Practical Process Improvement (PPI) tools.

Education

• Bachelor's degree in life sciences, chemistry, biotechnology, or related sciences highly preferred or equivalent (3-4) years work experience.
• High school diploma required.

Experience

• 3 - 5+ years proven experience in an FDA regulated environment (drugs, biologics, medical devices or related products) including in a Quality Assurance or Quality Control role.
• Experience with manufacturing and QC testing including qPCR technologies a plus

Knowledge, Skills, Abilities

• Strong understanding of regulations and standards (21CFR820, ISO13485, 14971 and IVDR)
• Ability to review technical documentation and data with excellent attention to detail
• Good 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
• Proficient with standard applications for handling and processing quality documentation, data, emails, and presentations
• Excellent judgement and creative problem-solving skills
• Energetic, flexible, collaborative, and proactive

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 global team of 90,000 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! 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.