QA Compliance Specialist – GMP Data & Regulatory Review

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

Job summary

SGS Consulting is seeking a Quality Assurance professional to perform QA review of GMP batch records and development studies, ensuring compliance with regulatory requirements and internal procedures. The role emphasizes data integrity, documentation accuracy, and cross-functional collaboration.

The ideal candidate has a Life Sciences or related degree with GMP experience and strong proficiency in Microsoft Office. Knowledge of cGMPs for biotechnology or pharmaceutical sectors is a plus.

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 2-3 years QA experience in GMP-regulated industry.
• Alternatively, 1-2 years with Masters degree.
• Proficient in Microsoft Office (Excel and PowerPoint).

Responsibilities

• QA review of GMP batch records, in-process, release, and stability data to ensure regulatory compliance.
• QA review of development studies for regulatory submissions, including draft batch records, analytical/test records, and calibration records.
• Identify and report documentation errors and deviations from SOPs and specifications in a timely manner.
• Collaborate 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

Masters degree

Job description

SGS Consulting is seeking a Quality Assurance professional to perform QA review of GMP batch records and development studies, ensuring compliance with regulatory requirements and internal procedures. The role emphasizes data integrity, documentation accuracy, and cross-functional collaboration.

The ideal candidate has a Life Sciences or related degree with GMP experience and strong proficiency in Microsoft Office. Knowledge of cGMPs for biotechnology or pharmaceutical sectors is a plus.