New · posted Oct 30
Thermo Fisher Scientific · Pharmaceuticals
Quality Specialist II
- Florence, SC
- On-site
- Full-time
- Associate & Specialist
The role
Discover Impactful Work
Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.
What you need
Keys to Success
• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
• Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, Documentum, or equivalent)
• Experience in deviation investigations, CAPA, change control, and root cause analysis
• Proficient in Microsoft Office suite and quality management software systems
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Experience conducting internal audits and supporting external regulatory inspections
• Project management and organizational skills
• Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
What you'll do
Day in the Life
- Review and approve Standard Operating Procedures(SOPs), test methods, specifications, stability reports, and validation protocols and reports to ensure compliance with established quality standards and regulatory requirements
- Review and approve change controls, deviations, investigations, and CAPAs
- Assist in establishing, revising , and maintaining SOPs, including periodic reviews to ensure procedures remain accurate, current, and compliant with applicable requirements
- Maintain a thorough understanding of ICH guidelines, FDA regulations, and applicable quality standards. Apply this knowledge to support and justify quality-related decisions
- Review and approve stability protocols and reports
- Review and approve reference standard protocols and qualification data
- Apply critical thinking, technical expertise, and independent judgment to evaluate quality issues, resolve daily challenges, and make informed, risk-based decisions
- Independently prioritize and manage multiple assignments to meet operational deadlines
- Collaborate with other departments to streamline operations and create efficient solutions
- Communicate effectively with Project Management, Analytical Research and Development, and Quality Control Departments to support project deliverables, address quality concerns, and maintain alignment with business objectives
- Perform other duties as required to support departmental objectives, regulatory compliance, and overall business operations
Pay
Thermo Fisher Scientific didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
· Benefits & Total Rewards | Thermo Fisher Scientific
· Medical, Dental, & Vision benefits-effective Day 1
· Paid Time Off & Designated Paid Holidays
· Retirement Savings Plan
· Tuition Reimbursement
Where you'll work
Florence, SCOn-siteOpen in Maps (opens in a new tab)
More jobs in Florence, SCSchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
From the posting
About Thermo Fisher
OTHER
· Relocation assistance is NOT provided
· Must be legally authorized to work in the United States now and in the future, without sponsorship.
· Must be able to pass a comprehensive background check, which includes a drug screening
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US191 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $81,000 | $95,250 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 988 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 13 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance5
- Lab testing and methods4
- Documentation and SOPs4
- Collaboration and leadership4
- Investigations and CAPA3
- Quality systems and risk3
- Validation and qualification2
- Data and digital systems1
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
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 84
- Open roles
- 74
- Distinct roles
- 37
- Locations
By discipline
- Quality77 92%
- Regulatory5 6%
- Compliance & Safety2 2%
By level
- Senior & Principal38 45%
- Associate & Specialist22 26%
- Manager21 25%
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Quality Specialist II at Thermo Fisher
Applications close November 5.