New · posted Oct 22
Thermo Fisher Scientific · Biotechnology
Quality Specialist III
- Plainville, MA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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 you need
What you'll do
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
Pay and benefits
$83,300 – $125,000 a year
Employer providedThe 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
Medical, dental and vision plans
Paid time off and 10 paid holidays
Paid parental leave
401(k) retirement plan
Employee Stock Purchase Plan
Tuition reimbursement
Where you'll work
Plainville, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Plainville, MASchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts26 roles publishing pay
Senior & Principal roles in the US307 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $83,300 | — | $125,000 |
| Massachusetts (middle half) | $105,125 | $121,000 | $133,000 |
| All US (middle half) | $102,000 | $119,000 | $137,500 |
This role: Thermo Fisher Scientific's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 915 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 14 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Quality systems and risk8
- Collaboration and leadership6
- Investigations and CAPA5
- Documentation and SOPs4
- Data and digital systems2
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Thermo Fisher on Regulatory Jobs
- 87
- Open roles
- 74
- Distinct roles
- 36
- Locations
By discipline
- Quality78 90%
- Regulatory7 8%
- Compliance & Safety2 2%
By level
- Senior & Principal35 40%
- Associate & Specialist27 31%
- Manager20 23%
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Quality Specialist III at Thermo Fisher
Open until filled. $83K–$125K a year, employer provided.