GMP QA Specialist – CMC Quality Assurance

SGS Consulting; Milton (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

SGS Consulting in Milton, MA seeks a Quality Assurance professional to review GMP analytical batch records, in-process, release, and stability data to ensure regulatory compliance and internal quality standards. The role also covers QA review of development studies for regulatory submissions, including draft batch records and calibration logs, ensuring adherence to approved protocols and global guidelines.

Requires a Life Sciences/Engineering/Chemistry degree with 2–3 years of QA GMP exp or 1–2

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 2-3 years QA GMP experience in GMP-regulated industry; or 1-2 years with Masters.
• Fluent in Microsoft Office (Excel, PowerPoint).
• Preferred: knowledge of cGMPs for biotech, cell/gene therapy and international regulatory requirements.

Responsibilities

• Performs QA review of executed GMP analytical batch records, in-process, release, and stability data to ensure regulatory compliance and internal quality standards.
• Performs QA review of developed studies for regulatory submissions, including draft batch records, analytical test records, and calibration records.
• Identifies and reports documentation errors and deviations from SOPs or specifications in a timely manner.
• Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

Skills

Quality Assurance

Data Review

QA Review

GMP

Education

BS/BA in Life Sciences, Engineering, or Chemistry with 2-3 years QA GMP experience

Job description

SGS Consulting in Milton, MA seeks a Quality Assurance professional to review GMP analytical batch records, in-process, release, and stability data to ensure regulatory compliance and internal quality standards. The role also covers QA review of development studies for regulatory submissions, including draft batch records and calibration logs, ensuring adherence to approved protocols and global guidelines.

Requires a Life Sciences/Engineering/Chemistry degree with 2–3 years of QA GMP exp or 1–2