Quality Specialist III (1 Day Shift & 2 Night Shift Positions)
Thermo Fisher Scientific
Summary
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.
Job description
Discover Impactful Work
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.
A Day in the Life
- Collaborate 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.
Education
- At least an Associate's degree required.
- BS Degree highly preferred.
- Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field.
- Project management experience preferred.
Experience
- 5+ years of experience with Associates, or 3-5 years of experience with a BS degree in quality assurance/quality control within regulated industries required (pharmaceutical, medical device, biotech preferred).
- Experience with quality management systems, CAPA processes, deviation management, and change control.
- Experience conducting and hosting internal/external audits and regulatory inspections.
Knowledge, Skills, Abilities
- Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
- 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
- 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 0 to 25% travel
- Physical ability to work in manufacturing environments with PPE requirements as needed
- Knowledge of risk assessment methodologies and continuous improvement tools
Requirements
- At least an Associate's degree required
- BS Degree highly preferred
- Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field
- Project management experience preferred
- 5+ years of experience with Associates, or 3-5 years of experience with a BS degree in quality assurance/quality control within regulated industries required
- Experience with quality management systems, CAPA processes, deviation management, and change control
- Experience conducting and hosting internal/external audits and regulatory inspections
- Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
- 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
- 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 0 to 25% travel
- Physical ability to work in manufacturing environments with PPE requirements as needed
- Knowledge of risk assessment methodologies and continuous improvement tools
Benefits
- Annual Incentive Plan Bonus
- Healthcare
- Employee Benefits
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.