Senior Quality Assurance Lead, GMP & Continuous Improvement

Endo; Rochester (MI); On-site; USD 85,000 - 120,000; Full time

Job summary

Par Health is seeking a Senior Quality Specialist to review batch records, certificates of analysis, and quality events, ensuring timely, compliant product release. This role involves on-the-floor QA activities, collaboration with manufacturing and QA teams, and leadership in quality initiatives.

You will lead investigations, CAPAs, and corrective actions, support audits and regulatory readiness, and contribute to a culture of quality, safety, and continuous improvement across the organization.

Qualifications

• 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.
• 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.
• Proficiency with quality management systems, ERP systems, and Microsoft Office applications.
• Strong analytical and problem-solving abilities; attention to detail.

Responsibilities

• Perform Manufacturing Quality Assurance 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.
• 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.
• 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.
• 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.
• 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.

Education

Bachelor's degree in a scientific, technical, engineering, quality, or related discipline

Tools

ERP systems

Microsoft Office

Job description

Par Health is seeking a Senior Quality Specialist to review batch records, certificates of analysis, and quality events, ensuring timely, compliant product release. This role involves on-the-floor QA activities, collaboration with manufacturing and QA teams, and leadership in quality initiatives.

You will lead investigations, CAPAs, and corrective actions, support audits and regulatory readiness, and contribute to a culture of quality, safety, and continuous improvement across the organization.