Sr QA Specialist - Quality Risk Management

Work Schedule First Shift (Days) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Excellent Benefits Package Review our company's Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 5% Tuition Reimbursement - eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Location/Division Specific Information Greenville, NC

RELOCATION ASSISTANCE IS NOT PROVIDED

Must be legally authorized to work in the United States

WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.

Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

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 Advanced degree with 6+ years of experience, or bachelor's degree with 8+ years of experience in quality assurance within a GMP regulated pharmaceutical or biotech environment Preferred fields: Chemistry, Biology, Microbiology, Engineering, Validation, or related technical disciplines Experience

MUST HAVE MEDICAL DEVICE EXPERIENCE

Strong experience in GMP regulated pharmaceutical/biotech environments Proven expertise in investigations, CAPAs, change control, and document control 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 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 Competencies Quality focused Detail oriented Collaborative Analytical thinker Effective communicator Results driven Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.