Work ScheduleFirst Shift (Days)
Environmental ConditionsOffice, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job DescriptionDESCRIPTION:
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:
• 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)
• Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field
• 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
Location, Work Authorization & Pre-Employment RequirementsPlease review the following requirements before applying:
- Relocation: Relocation assistance is not available for this position.
- Work Authorization: Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization.
- Pre-Employment Screening: Employment is contingent upon successful completion of all applicable pre-employment requirements, including a background check and drug screening, in accordance with company policy and applicable law.
