Compliance Specialist CMC, Quality Assurance

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

Job Responsibilities

• Performs QA review of executed GMP analytical batch records; in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, internal procedures, and contribute to the overall Quality Assurance processes.
• Performs QA review of executed development studies intended for regulatory submissions, included but not limited to, draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
• Identifies and reports documentation errors and deviations from test / data records, protocols, Standard Operating Procedures (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 / Experience

BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred Qualifications

Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.

Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.