Senior Quality Assurance & Continuous Improvement Lead

Endo Pharmaceuticals; Rochester (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

Par Health is seeking a Senior Quality Specialist to review batch records and COAs, ensuring release compliance and timely action on quality events. You will partner with cross-functional teams to address errors, place lots on Quality Hold when needed, and support quality metrics for leadership reviews.

You will lead defect characterization, trend analysis, and collaboration with manufacturing, QA, and packaging teams to ensure product quality and regulatory readiness, including on-the-floor

Qualifications

• Experience in quality assurance and regulatory compliance (GMP/cGMP).
• Ability to analyze data and compile metrics for management review.
• Familiarity with CAPA, change controls, deviations and audits.

Responsibilities

• Review batch records, production documentation, logbooks and quality records for accuracy and compliance.
• Classify defects and support product quality decisions with cross-functional teams.
• Lead investigations and implement CAPAs; support audits and regulatory readiness.
• Support process improvements and participate in validation and qualification activities.
• Provide training and guidance on defect recognition and quality assessment.

Skills

Quality Assurance

GMP knowledge

Data analysis

Tools

ERP systems

Job description

Par Health is seeking a Senior Quality Specialist to review batch records and COAs, ensuring release compliance and timely action on quality events. You will partner with cross-functional teams to address errors, place lots on Quality Hold when needed, and support quality metrics for leadership reviews.

You will lead defect characterization, trend analysis, and collaboration with manufacturing, QA, and packaging teams to ensure product quality and regulatory readiness, including on-the-floor