Senior Quality Specialist
Endo
Summary
The Senior Quality Specialist reviews all pertinent records, including Batch Records and laboratory Certificates of Analysis to confirm accuracy, and makes the determination of acceptability for product release. In addition, confirms that all related Quality events such as CAPAs, Change Controls, etc. are closed prior to releasing the product. Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, assesses compliance risk, decides when to escalate to supervision, and takes action to place lots on Quality Hold as needed. Ensures release meets internal requirements and is performed in a timely and accurate manner. Compiles timely and accurate data for business metrics, analyzes and summarizes for Quality Management Review Index. Leads or participates on cross-functional teams for continuous improvements. May participate in 'on the floor' Quality activities during product manufacturing.
Job description
Key Responsibilities
Batch Record & Production Review
- Perform Manufacturing Quality Assurance (MQA) activities on the manufacturing floor, including line clearances, room and equipment inspections, cleaning verifications, and material releases.
- Review batch records, production documentation, logbooks, and supporting quality records for accuracy, completeness, and compliance.
- Reconcile documentation discrepancies and support timely resolution of production and quality issues.
- Execute product release, quarantine, segregation, and hold activities within applicable quality and ERP systems.
- Support internal audits, GMP walkthroughs, quality inspections, and regulatory audit readiness activities.
- Escalate quality concerns and potential product-impacting issues to management as appropriate.
Defect Characterization & Product Quality Assessment
- Evaluate, characterize, and classify defects identified during incoming, in-process, finished product, retain, and investigation sample inspections.
- Classify defects according to established quality standards as Critical, Major, or Minor and document supporting rationale.
- Perform defect sub-classification activities to support investigations, trend analysis, and continuous improvement efforts.
- Assess visible particulates, cosmetic defects, container closure concerns, and other product quality observations for potential product impact.
- Collaborate with Visual Inspection, Packaging, Manufacturing, and Quality teams to evaluate inspection findings and support product quality decisions.
- Maintain accurate defect characterization documentation in accordance with cGMP and internal procedural requirements.
- Support development and maintenance of defect libraries, inspection standards, and characterization guides.
Quality Management Systems & Continuous Improvement
- Initiate, complete, and support quality system records including deviations, investigations, change controls, holds, CAPAs, and document revisions.
- Lead or participate in investigations related to product defects, quality events, inspection findings, and manufacturing deviations.
- Apply quality risk assessment principles and scientific judgment to support investigation outcomes and product impact assessments.
- Recommend and implement corrective and preventive actions (CAPAs) to address recurring quality issues.
- Review and update Quality procedures and standard operating procedures (SOPs).
- Identify opportunities for process improvements and support implementation of quality and operational excellence initiatives.
- Participate in process validation, equipment qualification, and continuous improvement projects as a Quality representative.
Training & Technical Support
- Serve as a qualified trainer for quality systems, procedures, and inspection-related activities.
- Provide coaching and technical guidance regarding defect recognition, classification, and quality assessment practices.
- Support development of inspection personnel through training and knowledge sharing.
Compliance & Quality Culture
- Ensure compliance with cGMP, GDP, FDA, USP, DEA, and company quality requirements.
- Support customer, internal, and regulatory audits and inspections.
- Promote a culture of quality, compliance, safety, and continuous improvement.
- Communicate quality metrics, trends, and significant events to stakeholders and operational teams.
Requirements
- Bachelor's degree in a scientific, technical, engineering, quality, or related discipline
- Minimum of 7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
- Experience in Quality Assurance, Manufacturing Quality Assurance, Quality Control, Inspection, or Quality Systems functions
- Working knowledge of cGMP, GDP, FDA regulations, and pharmaceutical quality systems
- Knowledge of sterile manufacturing processes and aseptic operations
- Knowledge of visual inspection processes, defect characterization methodologies, and defect classification standards
- Familiarity with USP and regulatory guidance related to visual inspection, visible particulates, and product quality evaluation
- Knowledge of investigation practices, root cause analysis, CAPA development, and quality risk assessment
- Proficiency with quality management systems, ERP systems, and Microsoft Office applications
- Critical Thinking
- Analytical Problem Solving
- Scientific Judgment
- Quality Risk Assessment
- Investigation and Root Cause Analysis
- Technical Writing and Documentation
- Attention to Detail
- Decision Making
- Technical Communication
- Training and Coaching
- Cross-Functional Collaboration
- Continuous Improvement Mindset
- Organization and Prioritization Skills
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.