Compliance Specialist

Crystal Equation Corporation; Westborough (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Crystal Equation Corporation is seeking a Compliance Specialist CMC, Quality Assurance to perform critical QA tasks supporting GMP and non-GMP manufacturing programs and Regulatory Submissions. The role focuses on ensuring data integrity, quality, and compliance across QA areas, partnering with cross-functional teams to uphold high standards for patients.

The candidate will review development studies, draft batch records and analytical records for regulatory submissions, and communicate QA

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA experience in GMP-regulated industry.
• Masters degree reduces experience requirement by 1–2 years.
• 6+ years of biotechnological/pharma QA experience if no Life Sciences degree; high technical aptitude and attention to detail.

Responsibilities

• Performs QA review of development studies for regulatory submissions, including draft batch records, analytical test records and calibration records.
• Communicates QA review results and reporting to stakeholders.
• Collaborates with cross-functional teams to ensure quality events and proper quality records with supporting evidence.

Skills

QA experience GMP

Regulatory submissions support

Attention to detail

Education

BS/BA in Life Sciences, Engineering or Chemistry

Masters degree (advantage)

Tools

Microsoft Office

Job description

The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts to help ensure high quality standards and value delivery for our patients.

Responsibilities

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

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 Protocols, SOPs or specifications in a timely manner.

Responsible for communicating QA review, audit results and reporting.

Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence

Required Skills

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 Skills

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