Quality Assurance Specialist II — GMP & Regulatory Expert

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

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