Principal Quality Specialist
Endo
Summary
The Principal Quality Specialist, Operations is responsible for providing Quality Assurance oversight and technical leadership within a sterile pharmaceutical manufacturing environment. This role supports Manufacturing Quality Assurance (MQA) activities through on-the-floor quality monitoring, batch record review, quality systems support, and product disposition activities. The position serves as a subject matter expert in defect characterization and quality risk assessment, evaluating product defects, determining potential product impact, and supporting investigations, quality decisions, and continuous improvement initiatives.
Job description
Key Responsibilities
Manufacturing Quality Assurance Oversight
- Perform routine quality oversight activities during manufacturing operations, including in-process inspections, line clearances, room releases, cleaning verifications, and product release activities.
- Provide real-time quality guidance to manufacturing personnel and ensure compliance with cGMP, GDP, SOPs, and regulatory requirements.
- Review and approve production documentation, batch records, logbooks, and associated quality records for completeness and accuracy.
Defect Characterization & Product Quality Assessment
- Evaluate, characterize, and classify product defects identified during in-process, finished product, retain, and investigation sample inspections.
- Classify defects as Critical, Major, or Minor in accordance with established quality standards and regulatory requirements.
- Perform defect sub-classification and trending activities to support investigations, risk assessments, and continuous improvement initiatives.
- Assess visible particulates, cosmetic defects, container closure concerns, and other quality observations to determine potential product impact.
- Provide technical justification and documented rationale supporting defect characterization and quality decisions.
- Support development and maintenance of defect libraries, inspection standards, and characterization guides.
Quality Systems & Investigations
- Initiate and support quality system records including deviations, investigations, change controls, holds, CAPAs, and document revisions.
- Lead or support investigations involving product defects, visible particulate contamination, inspection findings, and process non-conformances.
- Apply scientific judgment and quality risk assessment principles to evaluate product impact and recommend appropriate corrective actions.
- Communicate and defend defect classifications, quality assessments, and investigation conclusions to cross-functional stakeholders.
Continuous Improvement
- Identify opportunities to improve product quality, inspection processes, quality systems, and manufacturing operations.
- Analyze defect trends and recurring quality issues to drive sustainable corrective and preventive actions.
- Participate in process improvement, validation, qualification, and operational excellence initiatives.
Requirements
- Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or a related technical discipline
- Minimum of 9 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
- Experience supporting Quality Assurance, Manufacturing Quality Assurance, Quality Systems, or Quality Control activities
- Strong knowledge of cGMP, GDP, FDA regulations, and pharmaceutical quality systems
- Understanding of sterile manufacturing processes, aseptic practices, and contamination control principles
- Knowledge of visual inspection principles, defect characterization, defect classification, and quality risk assessment methodologies
- Familiarity with USP and industry guidance related to visual inspection, visible particulates, and product quality evaluation
- Proficiency with electronic quality systems, ERP systems, and Microsoft Office applications
Company overview
Endo is a diversified specialty pharmaceutical company headquartered in Malvern, Pennsylvania, founded in 1997. As a global pharmaceutical manufacturer, Endo develops and markets high-value branded pharmaceutical products across therapeutic areas including urology, men's health, orthopedics, and endocrinology. The company operates as a subsidiary of Endo International plc and has established itself as a leader in both branded and generic pharmaceuticals, with a portfolio of over 200 product families. Endo's mission focuses on helping everyone they serve live their best life through the delivery of life-enhancing therapies. The company maintains manufacturing and research facilities across multiple continents, including the United States, Ireland, Canada, and India, employing approximately 2,100-3,100 professionals globally. In 2025, Endo completed a significant merger with Mallinckrodt Pharmaceuticals, resulting in the creation of two focused standalone companies: Keenova Therapeutics for branded therapeutics and Par Health for generics and sterile injectables.