Senior Quality Leader, Sterile Pharma Operations

Endo Pharmaceuticals; Rochester (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Par Health is seeking a Principal Quality Specialist, Operations to provide on-the-floor QA oversight in a sterile pharmaceutical manufacturing environment. You will support Manufacturing Quality Assurance activities, review documentation, and contribute to defect analysis and continuous improvement initiatives.

The role requires a strong background in cGMP, regulatory expectations, and collaboration with cross-functional teams to ensure product quality and compliance.

Qualifications

• Bachelor’s degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or related technical discipline.
• Minimum of 9 years in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience supporting Quality Assurance, Manufacturing Quality Assurance, Quality Systems, or Quality Control activities.

Responsibilities

• Provide QA oversight during manufacturing operations, including in-process inspections, line clearances, room releases, cleaning verifications, and product release activities.
• Review and approve production documentation, batch records, logbooks, and associated quality records for completeness and accuracy.
• Evaluate, classify, and trend product defects; support investigations, risk assessments, and corrective actions.
• Lead or support investigations involving product defects, visible particulates, inspection findings, and process non-conformances.
• Identify opportunities to improve product quality, inspection processes, quality systems, and manufacturing operations.

Skills

QA Oversight

Cross-functional collaboration

Problem-solving

Technical writing

Education

Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or related

Job description

Par Health is seeking a Principal Quality Specialist, Operations to provide on-the-floor QA oversight in a sterile pharmaceutical manufacturing environment. You will support Manufacturing Quality Assurance activities, review documentation, and contribute to defect analysis and continuous improvement initiatives.

The role requires a strong background in cGMP, regulatory expectations, and collaboration with cross-functional teams to ensure product quality and compliance.