Thermo Fisher Scientific

Product Compliant Investigator III - Medical Device

Thermo Fisher Scientific$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in health science, life science, engineering, or related discipline.
  • Minimum of 4 years of progressive pharmaceutical or biotechnology industry experience.
  • Experience conducting GMP investigations involving product complaints, deviations, or quality events strongly preferred.
  • CDMO and/or sterile manufacturing experience is a plus.
  • Strong knowledge of cGMP regulations, quality systems, and pharmaceutical manufacturing.

Responsibilities

  • Lead end-to-end product complaint investigations of moderate to high complexity.
  • Conduct root cause analysis, risk assessments, and document investigations according to cGMPs.
  • Evaluate product quality, patient safety, and regulatory impact, escalating critical issues appropriately.
  • Serve as a technical and regulatory resource during complaint investigations.
  • Partner with cross-functional teams to resolve complaints effectively.
  • Drive timely and effective implementation of CAPAs.
  • Author and revise complaint procedures and investigation reports.

Benefits

  • Support regulatory inspections and audits.
  • Mentor junior complaint investigators.
  • Opportunity to serve as QA Supervisor designee when required.
Full Job Description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Discover Impactful Work:

The QA Specialist III, Product Complaints provides technical leadership and independent Quality oversight for the investigation and resolution of product complaints in a regulated pharmaceutical CDMO environment. This role ensures compliance with global regulatory requirements while protecting patient safety, product quality, and customer confidence.

You will serve as a key technical and regulatory resource for complaint investigations, partnering cross-functionally to drive effective root cause analysis, risk assessment, and corrective actions that prevent recurrence and support continuous improvement.

A Day in the Life:
  • Lead end-to-end product complaint investigations of moderate to high complexity.
  • Conduct root cause analysis, risk assessments, and document investigations in compliance with cGMPs and quality systems.
  • Evaluate product quality, patient safety, and regulatory impact while escalating critical issues appropriately.
  • Serve as a technical and regulatory resource for complaint investigations.
  • Partner with Manufacturing, QC, Regulatory, Supply Chain, and customers to resolve complaints.
  • Drive timely and effective CAPA implementation.
  • Author and revise complaint procedures, work instructions, and investigation reports.
  • Support regulatory inspections, audits, and customer audits.
  • Manage multiple priorities in a fast-paced manufacturing environment.
  • Mentor junior complaint investigators.
  • Serve as QA Supervisor designee when required.
  • Perform other duties as assigned.
Keys to Success:
Education
  • Bachelor’s degree in health science, life science, engineering, or related discipline.
Experience
  • Minimum of 4 years of progressive pharmaceutical or biotechnology industry experience.
  • Experience conducting GMP investigations involving product complaints, deviations, or quality events strongly preferred.
  • CDMO and/or sterile manufacturing experience is a plus.
Knowledge, Skills, Abilities
  • Strong knowledge of cGMP regulations, quality systems, and pharmaceutical manufacturing.
  • Ability to independently assess complex quality issues and risk.
  • Excellent written and verbal communication skills.
  • Strong organizational skills with ability to manage multiple priorities.
  • Excellent documentation and attention to detail.
  • Self-motivated with ability to work independently.
  • Comfortable working in a fast-paced regulated manufacturing environment.
Physical Requirements / Work Environment
  • Requires standing, walking, sitting, lifting up to 35 pounds, manual dexterity, visual acuity, and prolonged computer use in an office/manufacturing environment.

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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