Quality Specialist III

Work Schedule

Standard (Mon-Fri)

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 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 lead inspection readiness, head the local audit hosting team, and manage corporate document site implemenations. This role involves collaborating with cross-functional teams to ho conduct audits, investigate quality issues, manage documentation, and implement corrective actions while fostering a culture of quality excellence throughout the organization.

What will you do?

• Lead and organize audits performed by third parties, external clients, and Agency inspections as needed.

• Manage internal actions associated with audits including audits responses, audit response CAPAs, and effectiveness checks.

• Act as site contact for client audit representatives to schedule, prep, and respond to audits.

• Represent site while working with global quality management system teams to support site implementations, complete and support gap assessments, and lead site inspection readiness program.

• Conduct QA assessments for change controls, quality issues, CAPA, effectiveness reviews GMP documentation, and contribute to multiple project teams as the quality decision maker.

• Lead and support deviations, investigations, and determine appropriate root cause and CAPAs while participating in cross functional project teams

• Act as secondary site expert on Global TrackWise for deviation, CAPA, and change controls

• Work with functional groups across the site to review and approve quality and technical documentation including Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), procedures, and work instructions.

• Act as internal auditor in support of site’s internal audit schedule, as needed.

• Supports performance objectives, development plans, and monitoring of performance progress for the site on quality system performance.

• Act as Audit SME for quality management reviews.

REQUIREMENTS:
• Advanced Degree plus 5 years of experience, or Bachelor's Degree plus 8 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 conducting and hosting internal/external audits and regulatory inspections
• 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
• 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

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $83,300.00–$125,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards