GMP QA & Compliance Specialist

astellas; Massachusetts; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

PTO including Vacation and Sick time

401(k) match

Company paid life insurance

Annual Corporate Bonus

Job summary

Astellas is seeking a Compliance Specialist in Westborough, MA to perform QA compliance tasks across GMP manufacturing programs and support from clinical trials through commercialization.

You will work with QA, QC, Materials Management, and Manufacturing to ensure high-quality standards for patients. A BS/BA in Life Sciences or related field with 2–3 years of QA experience, or 6+ years in biotech, is required.

Qualifications

• 2–3 years of related QA experience within GMP-regulated industry, or 1–2 years with a Master’s degree.
• Proficiency with the Microsoft Office suite (Excel and PowerPoint) is required.

Responsibilities

• Performs QA review of QC test records, raw material inspection records, batch records, and calibration records; reports deviations from SOPs or specifications.
• Assists with Deviation and CAPA programs, helps investigations, and may lead select deviation investigations.
• Supports internal audits as an assistant auditor to ensure GMP compliance.
• Participates in continuous improvement to improve efficiency and compliance.
• Assists in writing or revising SOPs for QA.

Skills

Quality Assurance

Education

BS/BA in Life Sciences or related field

Tools

Microsoft Excel

PowerPoint

Job description

Astellas is seeking a Compliance Specialist in Westborough, MA to perform QA compliance tasks across GMP manufacturing programs and support from clinical trials through commercialization.

You will work with QA, QC, Materials Management, and Manufacturing to ensure high-quality standards for patients. A BS/BA in Life Sciences or related field with 2–3 years of QA experience, or 6+ years in biotech, is required.