Compliance 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

Job Responsibilities:

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

Skills:

• Working fluency in Microsoft Office (Excel, PowerPoint, Word)
• Attention to detail, strong technical aptitude, and ability to make objective, risk-based decisions
• Knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements (preferred)
• Ability to interpret regulatory rules, guidance, and industry standards

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 a Master’s degree
• Candidates without a Life Sciences degree may be considered with 6+ years of industry experience in biotechnological/pharmaceutical quality, manufacturing, or other technical fields requiring high attention to detail