GMP Quality & Compliance Specialist

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions’ Riverview facility is seeking a Quality and Compliance Specialist to join the QA team. The role focuses on supporting GMP operations, batch records review, and ensuring documentation aligns with regulatory requirements under USFDA and international authorities.

You will lead audits, manage quality system documentation, and participate in continuous improvement, risk management, and data integrity initiatives, with weekend/holiday shifts as needed.

Qualifications

• Bachelor’s degree in physical/biological sciences or engineering with 1+ years’ GMP ops/quality experience
• Associate’s degree with 2+ years’ pharma ops/QA experience considered
• 3-5 years’ pharma ops/quality experience accepted without degree

Responsibilities

• Review batch production records and analytics to ensure GMP conformance
• Support internal/external audits and regulatory inspections
• Maintain and improve quality systems and data integrity
• Assist in risk management and data tracking for CAPA and investigations

Skills

GMP knowledge

Regulatory compliance

Quality assurance

Data integrity

Microsoft Office

TrackWise

SAP

MasterControl

FDA interactions

Analytical skills

Education

Bachelor’s degree in physical/biological sciences or engineering

Associate’s degree in related field

Experience without degree (3-5 years)

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Solutions’ Riverview facility is seeking a Quality and Compliance Specialist to join the QA team. The role focuses on supporting GMP operations, batch records review, and ensuring documentation aligns with regulatory requirements under USFDA and international authorities.

You will lead audits, manage quality system documentation, and participate in continuous improvement, risk management, and data integrity initiatives, with weekend/holiday shifts as needed.