Sr QA Specialist - Quality Risk Management

About this role

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 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

Similar jobs

• QA Specialist V-Quality Risk Management — Lonza · US - Portsmouth, NH
• Sr. Specialist, QA Operations — Bristol Myers Squibb · Indianapolis - RayzeBio - IN
• Sr QA Validation Specialist (Oversight) — Regeneron · RENSS - TEMPEL LN
• Senior Specialist, Quality Assurance — Cardinal Health · OH-Columbus PET-OSU
• Sr Quality Manager — Thermo Fisher Scientific · Marietta, Ohio, United States
• Senior Specialist Quality Assurance — Abbott · United States > Lake Forest : J55
• Sr. Quality Specialist — Globus Medical · Audubon, PA
• Senior Manager, Quality Assurance — Veratherapeuticsinc · Brisbane, CA