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 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. The Principal Quality Specialist partners closely with Operations, Inspection, Quality Control, Engineering, and Technical Services to ensure compliance with cGMP requirements, regulatory expectations, and internal quality standards.
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…