Senior Quality Specialist

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

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

Job Description Summary

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

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 elevate 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.

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, a