GMP Quality & Compliance Specialist — 24/7 Operations

Piramal Pharma Limited; Riverview (MI); On-site; USD 70,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions – Ash Stevens, LLC in Riverview, Michigan is seeking a Quality & Compliance Specialist to support GMP manufacturing operations. You will review batch records, support audits, maintain quality systems, and drive regulatory compliance for USFDA and international authorities.

Strong data integrity and documentation skills are essential. The role involves shift-based work, including weekends/holidays as needed, and collaboration with QA and production teams to ensure product

Qualifications

• Bachelor’s degree in physical or biological sciences or engineering with 1+ year of GMP operations/quality experience.
• Associate’s degree with 2+ years in pharmaceutical operations or quality assurance.
• 3–5 years of pharma operations/regulated life sciences experience accepted in lieu of degree.

Responsibilities

• Review batch production records and analytical test packages to ensure GMP conformance.
• Support internal and external audits and regulatory inspections.
• Maintain document tracking systems and master production records.
• Provide data and reports for quality metrics and management review.
• Participate in risk management activities and data integrity initiatives.
• Assist in investigations, CAPA, and deviation handling.

Skills

GMP knowledge

TrackWise

SAP

MasterControl

Data integrity

Regulatory knowledge

MS Office

Analytical skills

Communication

Auditing

Education

Bachelor’s degree in physical or biological sciences or engineering

Associate’s degree with 2+ years of pharma operations/QA

3–5 years experience in pharmaceutical operations/regulated life sciences

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Solutions – Ash Stevens, LLC in Riverview, Michigan is seeking a Quality & Compliance Specialist to support GMP manufacturing operations. You will review batch records, support audits, maintain quality systems, and drive regulatory compliance for USFDA and international authorities.

Strong data integrity and documentation skills are essential. The role involves shift-based work, including weekends/holidays as needed, and collaboration with QA and production teams to ensure product