GMP QA & Compliance Specialist

Crystal Equation Corporation; Westborough (MA); Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

QA experience GMP

Regulatory submissions support

Attention to detail

Educación

BS/BA in Life Sciences, Engineering or Chemistry

Masters degree (advantage)

Herramientas

Microsoft Office

Descripción del empleo

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