Thermo Fisher Scientific

Sr QA Specialist - Quality Risk Management

Thermo Fisher Scientific$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Associate or bachelor's degree in related field (e.g., Life Sciences, Business Administration)
  • 7+ years in pharmaceutical or medical device industries focusing on quality systems
  • Proven track record in managing deviations, CAPAs, and change controls
  • Experience with risk assessment methodologies and root cause analysis
  • Background in regulatory inspections and customer audits preferred
  • Familiarity with data integrity and computer system validation preferred
  • Strong command of FDA, EMA, and global GMP regulations

Responsibilities

  • Serve as subject matter expert on GMP quality systems
  • Conduct risk assessments using quality risk management principles
  • Lead deviation investigations and root cause analysis
  • Manage CAPAs to ensure timely and effective resolution
  • Ensure compliance with FDA, EMA, and other global regulatory standards
  • Support and host regulatory inspections and customer audits
  • Collaborate with cross-functional teams for continuous improvement
  • Contribute to data integrity and computer system validation initiatives

Benefits

  • First Shift work schedule
  • Office environmental conditions
  • Technical leadership in a reputable GMP setting
  • Opportunity to collaborate cross-functionally
  • Engagement with regulatory bodies and compliance efforts
Full Job Description
Work Schedule
First Shift (Days)

Environmental Conditions
Office

Job Description

As a Senior Quality Specialist, you will provide technical leadership and oversight within GMP manufacturing environments. You will partner cross functionally to drive quality excellence, ensure compliance with global regulatory requirements, and strengthen quality systems that support safe and effective products.

A Day in the Life:
  • Serve as a subject matter expert on GMP quality systems and regulatory expectations
  • Conduct risk assessments using quality risk management principles
  • Lead and support deviation investigations, including root cause analysis
  • Manage CAPAs to ensure effective and timely resolution
  • Ensure compliance with FDA, EMA, and global regulatory standards
  • Support and host regulatory inspections and customer audits
  • Collaborate with manufacturing, validation, and engineering teams to drive continuous improvement
  • Contribute to data integrity initiatives and computer system validation activities


Keys to Success:

Education

Associate degree or bachelor's degree in business administration, Data Science, Organizational Psychology, Life Sciences, or a closely related field.

Experience
  • 7+ years of experience in the pharmaceutical or medical device industry, with experience in quality systems, including risk management, manufacturing, validation/engineering, quality assurance, or other relevant areas within a GMP regulated medical device or combination product industry
  • Proven expertise in authoring and managing a combination of deviations, CAPAs, change controls, and document control workstreams
  • Experience with risk assessment methodologies and root cause analysis
  • Experience hosting regulatory inspections and customer audits preferred
  • Data integrity and computer system validation experience preferred


Knowledge, Skills, Abilities
  • Strong knowledge of FDA, EMA, and global GMP regulations (including 21 CFR Parts 210/211, 21 CFR Part 820, ISO 13485, and ICH guidelines)
  • Proficiency with quality management systems and standard office software
  • Excellent technical writing and documentation skills
  • Strong verbal and written communication skills
  • Demonstrated project management and organizational capabilities
  • Strong analytical and problem-solving skills
  • Ability to work independently and collaboratively across diverse teams
  • Customer focused mindset with strong attention to detail
  • Fluency in English required; additional languages are a plus

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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