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 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…