Quality Assurance Specialist I – GMP & CAPA Focus

Socket.dev; Woodmont (SC); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Annual incentive plan bonus

Healthcare benefits

Job summary

Thermo Fisher Scientific in Florence, SC is seeking a Quality Specialist I to ensure GMP compliance through thorough documentation review, process monitoring, and cross-functional collaboration. You will support batch disposition, investigations, and CAPA programs while maintaining inspection readiness.

Under supervision, you will help manage quality systems, perform deviations and change actions, and contribute to continual improvement across API manufacturing, testing, and distribution

Qualifications

• BS degree preferred in chemistry, biology, engineering, life sciences or related field.
• High school diploma required; relevant certifications are a plus.
• Iso/Six Sigma certifications are advantageous; pharma/biotech QA background preferred.

Responsibilities

• Review batch records and quality systems to ensure GMP compliance.
• Investigate quality events and drive CAPA and change controls.
• Support audits and regulatory inspections and ensure inspection readiness.
• Maintain quality documentation and provide QA oversight across manufacturing.
• Assist in SOP development and process improvements.

Skills

Analytical thinking

Documentation

Quality mindset

Communication

Independent work

Education

BS in Chemistry/Biology/Engineering

High School Diploma

ISO/Six Sigma cert advantageous

Tools

TrackWise

Documentum

EDMS

MS Office

Job description

Thermo Fisher Scientific in Florence, SC is seeking a Quality Specialist I to ensure GMP compliance through thorough documentation review, process monitoring, and cross-functional collaboration. You will support batch disposition, investigations, and CAPA programs while maintaining inspection readiness.

Under supervision, you will help manage quality systems, perform deviations and change actions, and contribute to continual improvement across API manufacturing, testing, and distribution