GMP QA Compliance Specialist

Astellas; Westborough (MA); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Paid Time Off and holidays

401(k) match and company contribution

Annual Corporate Bonus and Quarterly S

Long Term Incentive Plan

Company fleet vehicle

Job summary

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

You will collaborate with QA, QC, Materials Management, and Manufacturing to uphold high-quality standards delivering value to patients.

The role includes reviewing records, assisting CAPA and internal audits, and authoring SOPs to meet regulatory requirements. On-site work is required.

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA in GMP setting.
• Or 1–2 years with a Masters degree in a related field.
• Proficiency in Excel and PowerPoint required.

Responsibilities

• QA review of QC test records, raw material inspections, batch records, and calibrations.
• Support Deviation and CAPA programs; assist investigations and root cause analysis.
• Assist with internal audits to ensure GMP compliance.
• Contribute to continuous improvement and SOP updates.

Skills

Quality Assurance

Regulatory interpretation

Documentation review

Audit support

Education

BS/BA in Life Sciences, Engineering, or Chemistry

Masters degree (preferred)

Tools

Microsoft Office

Job description

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

You will collaborate with QA, QC, Materials Management, and Manufacturing to uphold high-quality standards delivering value to patients.

The role includes reviewing records, assisting CAPA and internal audits, and authoring SOPs to meet regulatory requirements. On-site work is required.