Quality Specialist II

Regulatory Jobs; Florence (SC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, & Vision benefits

Paid Time Off & Holidays

Retirement Savings Plan

Tuition Reimbursement

Job summary

Thermo Fisher Scientific in the United States is seeking a Quality Specialist II to ensure GMP/FDA compliance and support manufacturing across product lines. You will lead SOP and test method reviews, drive quality improvements, and collaborate with cross-functional teams to uphold global quality standards.

Responsibilities include approving change controls, investigations, CAPAs, and standing up robust quality systems; you will prioritize multiple tasks and communicate clearly with project

Qualifications

• Advanced degree or Bachelor’s degree with 2 years in pharma/biotech GMP environment.
• Knowledge of cGMP regulations, ISO 9001/13485, and international regs.
• Experience with quality management systems and docs (TrackWise, Documentum).
• Experience in deviation investigations, CAPA, change control, root cause analysis.
• Proficient in Microsoft Office suite and quality management software.
• Technical writing and documentation skills.
• Analytical and problem-solving abilities.
• Clear verbal and written communication skills.
• Ability to work independently and with cross-functional teams.
• Experience conducting internal audits and supporting regulatory inspections.
• Project management and organizational skills.
• Physical requirements: standing/walking and lifting up to 25 lbs.

Responsibilities

• Review and approve SOPs, test methods, specs, stability reports for compliance.
• Review and approve change controls, deviations, investigations, and CAPAs.
• Maintain SOPs with periodic reviews for accuracy and compliance.
• Apply ICH, FDA regs to support quality decisions.
• Review and approve stability protocols and reports.
• Review reference standard protocols and qualification data.
• Prioritize and manage multiple assignments to meet deadlines.
• Collaborate across departments to streamline operations.
• Communicate with PM, AR&D, and QC to support deliverables.
• Perform other duties to support compliance and operations.

Skills

Quality compliance

Analytical thinking

Problem-solving

Verbal and written communication

Independent work

Cross-functional collaboration

Project management

Education

Advanced degree

Bachelor's degree in Life Sciences or related field

Tools

TrackWise

Documentum

Quality management software

Job description

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 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.

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

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

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

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