Sr. Quality Specialist

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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 by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner and safer. This role involves collaborating with cross-functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actions while fostering a culture of quality excellence throughout the organization.

REQUIREMENTS:

• Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
• Experience with quality management systems, CAPA processes, deviation management, and change control
• Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation
• Proficiency in statistical analysis, data trending, and quality metrics reporting
• Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation
• Experience conducting and hosting internal/external audits and regulatory inspections
• Advanced problem-solving abilities and attention to detail
• Excellent verbal and written communication skills
• Strong interpersonal skills with ability to collaborate across functions and levels
• Proficiency with quality systems software (TrackWise, Document Control Systems) and Microsoft Office Suite
• Ability to work independently and guide cross-functional teams
• May require up to 25% travel
• Physical ability to work in manufacturing environments with PPE requirements as needed
• Knowledge of risk assessment methodologies and continuous improvement tools
• Project management experience preferred

EDUCATION:

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance/quality control within regulated industries (pharmaceutical, medical device, biotech preferred), or number of experience within industry/ process as equivalent.
• Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field