Thermo Fisher Scientific

Staff QA Engineer

Thermo Fisher Scientific$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Strong knowledge of GMP regulations, ISO standards, and FDA/EMA regulatory requirements.
  • Experience with internal and external audits, encompassing regulatory inspections.
  • Expertise in quality systems including CAPA, change control, document control, and risk management.
  • Proficiency in quality tools such as FMEA, root cause analysis, and statistical analysis.
  • Experience in validation activities including IQ/OQ/PQ and process validation.
  • Strong leadership skills in project management and cross-functional team coordination.
  • Excellent communication skills, both written and verbal.

Responsibilities

  • Ensure product quality and compliance with regulatory standards.
  • Conduct and manage internal audits and regulatory inspections.
  • Lead quality initiatives and drive continuous improvement efforts.
  • Collaborate with cross-functional teams to enhance quality programs.
  • Support validation activities for processes and systems.
  • Review and approve technical documentation, protocols, and reports.
  • Promote a culture of quality excellence within the organization.

Benefits

  • Collaborative work environment with emphasis on teamwork.
  • Opportunity to contribute to impactful scientific solutions.
  • Engagement in various quality improvement initiatives.
  • Career advancement opportunities in a leading scientific organization.
  • Flexible work schedule with standard office hours.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Join our collaborative team at Thermo Fisher Scientific as a Staff QA Engineer, where you'll contribute to ensuring product quality and regulatory compliance across our operations. You'll work at the intersection of quality assurance, regulatory compliance, and continuous improvement to help deliver life-changing solutions to our customers. Collaborate with cross-functional teams to advance quality initiatives, conduct audits, manage validation activities, and support a culture of excellence. Your expertise will directly impact our mission of enabling customers to make the world healthier, cleaner, and safer through innovative scientific solutions.

REQUIREMENTS:
• Strong knowledge of GMP regulations, ISO standards (9001, 13485), and regulatory requirements (FDA, EMA, etc.)
• Experience conducting internal and external audits, including regulatory inspections and client audits
• Expertise in quality systems including CAPA, change control, document control, and risk management
• Proficiency in quality tools and methodologies (FMEA, root cause analysis, statistical analysis)
• Experience with validation activities (IQ/OQ/PQ, process validation, computer system validation)
• Strong project management and cross-functional team leadership abilities
• Advanced problem-solving and analytical skills with attention to detail
• Excellent written and verbal communication skills
• Experience with quality management software systems (TrackWise, SAP, etc.)
• Knowledge of data integrity requirements and computer system compliance
• Ability to review and approve technical documentation, protocols, and reports
• Experience supporting quality professionals
• Travel up to 25% as required

Education:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of quality assurance experience in regulated environments (pharmaceutical, medical device, or biotech industry)
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, Biology, or related technical/scientific field
• Additional certifications preferred: ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or relevant industry certifications

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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