Compliance 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

Job Responsibilities:

• Essential Duties and Responsibilities include, but are not limited to, the following:
• 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.