Sr QA Specialist - Quality Risk Management

Thermo Fisher Scientific•Greenville, NC

2d•Onsite

About The Position

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. 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

Requirements

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
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

Nice To Haves

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
additional languages are a plus

Responsibilities

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