Quality Specialist II
Thermo Fisher Scientific · Florence, SC
- Level
- Specialist
- Team
- Quality
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Pharma & life sciences
- Posted
- Yesterday
The role in 30 seconds
A specialist quality role at Thermo Fisher Scientific (pharma & life sciences) in Florence, SC. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines.
- They ask for
- 2+ years · degree required
- Tools it names
- Root cause, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Internal audits
- Day to day
- some off-shift / weekend coverage · relocation help
Read from the posting. The full description is below.
From the plant jobs report · week of October 26, 2026
Quality Engineer roles in South Carolina: typical posted base $95k–$120k.
Median of the low and high ends of 19 live postings that list pay, out of 40 quality engineer openings in South Carolina, read from manufacturers' own careers sites.
South Carolina plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 39 other live quality postings in South Carolina.
- Base pay
- Not listed in this posting
- Experience asked
- Less than usual (2+ vs 5+)
Typical $90k–$120k, from 17 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 65%
- FMEA 43%
- New product launch 40%
- Supplier quality 40%
- SPC 40%
- Lean 38%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for ISO 13485, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Thermo Fisher Scientific
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How does off-shift and weekend coverage work?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Thermo Fisher Scientific in Florence
3 other open roles at this site.
- Process Technician I - Rotating Schedule · Process · Technician
- Process Technician I · Process · Technician
- Sr Automation Engineer · Controls · Senior
Full description from Thermo Fisher ScientificAs posted on their careers site.ShowHide
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.
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
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
Excellent Benefits
· Benefits & Total Rewards | Thermo Fisher Scientific
· Medical, Dental, & Vision benefits-effective Day 1
· Paid Time Off & Designated Paid Holidays
· Retirement Savings Plan
· Tuition Reimbursement
Show full description ↓Show less ↑
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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
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
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
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