New · posted Nov 10
Thermo Fisher Scientific · Pharmaceuticals
Quality Specialist I
- Florence, SC
- On-site
- Full-time
- Associate & Specialist
The role
Discover Impactful Work
Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide essential quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams. You'll help maintain GMP compliance, investigate quality events, and drive continuous improvement initiatives while working in a collaborative environment focused on delivering life-changing products to our customers.
Under general supervision, provide comprehensive manufacturing technical support and quality assurance oversight to meet good business practices and the requirements of applicable regulatory agencies, supporting one of the following areas: API manufacturing, testing, disposition, quality systems and distribution of bulk drug substance.
What you need
Education
- High School diploma, or equivalent required.
- BS Degree Preferred. Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
- Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous.
Experience
- High school diploma with 3–5 years of experience in pharmaceutical or biological manufacturing, or another regulated industry; or a bachelor’s degree in a technical science or engineering field with 0–3 years of Quality Assurance experience.
- Experience conducting quality investigations and root cause analysis.
Knowledge, Skills, Abilities
- Thorough knowledge of FDA, EMA, and international GMP regulations
- Proven ability to review and approve GMP documentation, batch records, and quality records
- Strong understanding of quality management systems and tools (e.g. CAPA, change control)
- Excellent documentation and technical writing skills
- Proficiency with quality systems software and Microsoft Office applications
- Strong analytical and problem-solving abilities with keen attention to detail
- Outstanding verbal and written communication skills
- Ability to work independently and collaborate effectively across functions
- Knowledge of environmental monitoring and contamination control principles
- Flexibility to work various shifts as needed to support manufacturing operations
- Ability to gown and work in controlled manufacturing environments when required
- Physical capability to stand, walk, and lift up to 25 pounds occasionally
- Sound judgment and decision-making skills
- Commitment to maintaining a quality-focused culture and driving continuous improvement
- Fluency in English required, additional language skills beneficial
What you'll do
Day in the Life
- Apply technical knowledge to address a broad range of issues to ensure adherence to and compliance with established company policies and procedures, as well as requirements of applicable Regulatory Agencies by working collaboratively with one or more of the following areas: manufacturing, testing, batch disposition, quality systems (Discrepancy/Investigation, change control, CAPA), qualification-validation, and distribution of bulk drug substance. Maintains quality management system associated documentation and all records required to manage the development, production and distribution of the products manufactured at this facility.
- Provide direct support to archival and retrieval of documentation and/or drawings to and from approved storage areas.
- Provide support in the monitoring and analyzing of business process performance measures and notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Ensure that the products are manufactured in compliance with the regulatory and in a GMP compliant manner by reviewing batch records and performing appropriate investigations.
- Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and system issues.
- Assist in writing and revising site SOPs or other procedures as required. Administer, document and maintain the company Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of the company’s Quality Systems and tools, as well as direct actions.
- Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
- Support Site Training in development, delivery and maintenance of Quality training programs (e.g., CAPA process, GMP, etc.).
- Participate in audits and inspections performed by clients and regulatory agencies, as required.
- Participate in the execution and/or administration of corporate Quality System tools such as TrackWise, Documentum, EDMS, etc.
- Provide input to the development of personal performance goals and departmental objectives; collaborate with Management to establish and meet targets and timelines.
- Participate in the design and implementation of department and cross-functional initiatives. Maintain a state of inspection readiness.
- Perform other duties as required.
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 or 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 · November 10, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $81,875 | $88,250 | $97,375 |
Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 103 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Documentation and SOPs8
- Quality systems and risk8
- Collaboration and leadership7
- Investigations and CAPA6
- Lab testing and methods3
- Data and digital systems2
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Thermo Fisher on Regulatory Jobs
- 118
- Open roles
- 118
- Distinct roles
- 52
- Locations
By discipline
- Quality75 61%
- Clinical42 34%
- Regulatory6 5%
By level
- Senior & Principal57 46%
- Associate & Specialist35 28%
- Manager25 20%
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Quality Specialist I at Thermo Fisher
Open until filled.