Senior Quality Specialist, Sterile Pharma Operations

Par Health; Rochester (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Par Health in Rochester, MI seeks a Principal Quality Specialist, Operations to provide QA oversight in a sterile manufacturing setting. You will lead defect classification and investigations, support quality systems, and drive continuous improvement in cGMP compliance with cross-functional partners.

Responsibilities include real-time QA guidance, batch record review, and ensuring regulatory adherence while supporting product disposition decisions and quality risk assessments.

Qualifications

• Bachelor's degree in a scientific or engineering discipline with extensive regulated manufacturing experience.
• Minimum 9 years in pharmaceutical/biotech/regulated environments with QA/QC exposure.
• Experience supporting QA, MQA, quality systems, or QC activities.

Responsibilities

• Provide QA oversight in sterile manufacturing and ensure cGMP compliance.
• Evaluate defects, classify as Critical/Major/Minor, and support investigations.
• Lead or support deviations, investigations, CAPAs, and change controls.
• Communicate defect classifications and quality decisions to stakeholders.
• Identify opportunities for process and quality system improvements.
• Work with cross-functional teams to ensure product quality and compliance.

Skills

Quality Assurance

cGMP knowledge

Defect characterization

Investigations

CAPA

Process improvement

Regulatory compliance

Visual inspection

ERP systems

MS Office

Education

Bachelor's degree in Science/ Biology/ Chemistry/ Microbiology/ Engineering/ Quality

Tools

ERP systems

Electronic quality systems

Job description

Par Health in Rochester, MI seeks a Principal Quality Specialist, Operations to provide QA oversight in a sterile manufacturing setting. You will lead defect classification and investigations, support quality systems, and drive continuous improvement in cGMP compliance with cross-functional partners.

Responsibilities include real-time QA guidance, batch record review, and ensuring regulatory adherence while supporting product disposition decisions and quality risk assessments.