GMP Quality Assurance Specialist

SGS Consulting; Boston (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

SGS Consulting in Boston seeks a QA professional to perform GMP batch record reviews, in-process data review, release and stability assessments to ensure regulatory compliance and internal standards.

You will also review development studies for regulatory submissions, identify documentation errors, and collaborate with cross-functional teams to ensure quality records are clear, evidence-based, and well-documented.

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA in GMP-regulated industry, or 1–2 years with a Master’s degree
• Candidates without Life Sciences degree may be considered with 6+ years of related biotech/pharma QA experience
• Experience reviewing batch records, development studies, test records, calibration records

Responsibilities

• Perform QA review of GMP batch records, in-process, release, and stability data to ensure compliance with regulatory requirements and internal standards
• Review development studies for regulatory submissions, including draft batch records, test records, and calibration records, ensuring compliance with protocols and global standards
• Identify and report documentation errors and deviations from SOPs, protocols, or specifications in a timely manner
• Collaborate with cross-functional stakeholders regarding quality events, ensuring clear, technically sound records supported by evidence

Skills

MS Office

Attention to detail

cGMP knowledge

Regulatory interpretation

Education

BS/BA in Life Sciences, Engineering, or Chemistry

Master's degree preferred

Job description

SGS Consulting in Boston seeks a QA professional to perform GMP batch record reviews, in-process data review, release and stability assessments to ensure regulatory compliance and internal standards.

You will also review development studies for regulatory submissions, identify documentation errors, and collaborate with cross-functional teams to ensure quality records are clear, evidence-based, and well-documented.