Quality & Compliance Specialist - GMP & Audits

Piramal Pharma Limited; Riverview (MI); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions' Ash Stevens, LLC in Riverview, Michigan seeks a Quality & Compliance Specialist to join the QA team. The role emphasizes supporting GMP-compliant manufacturing operations and adherence to US FDA expectations across clinical and commercial activities.

The successful candidate will help implement and maintain Quality Systems, review documentation for batch release, and support audits and inspections. Weekend/holiday rotation may be required.

Qualifications

• Bachelor's degree in a life sciences field or related discipline.
• Knowledge of GMP and regulatory requirements with QA/QC exposure.
• Strong documentation and data integrity mindset.

Responsibilities

• Review batch production records, SOPs and release documents to ensure GMP conformance and proper corrective actions.
• Provide Operations support by reinforcing GMP practices and addressing deviations in real time.
• Assist QA administrative duties including master production records, labeling and document control.
• Support internal and external audits and regulatory inspections, including data gathering and audit follow-up.
• Assist in reports and document management such as Product Reviews and investigation reports.
• Support Quality Systems and continuous improvement initiatives across production and QA activities.

Job description

Piramal Pharma Solutions' Ash Stevens, LLC in Riverview, Michigan seeks a Quality & Compliance Specialist to join the QA team. The role emphasizes supporting GMP-compliant manufacturing operations and adherence to US FDA expectations across clinical and commercial activities.

The successful candidate will help implement and maintain Quality Systems, review documentation for batch release, and support audits and inspections. Weekend/holiday rotation may be required.