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