Quality Assurance Specialist
Integrated Resources, Inc ( IRI ), Florida, NY, United States
This position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production, Engineering, Quality Control (QC) Laboratory, and related support areas, ensuring timely root cause identification, appropriate product impact assessments, and implementation of effective Corrective and Preventive Actions (CAPAs) to maintain compliant supply.
The role applies scientific and technical judgment to evaluate manufacturing and laboratory data, interviews and observation, equipment/utilities performance, and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g., blending, granulation, compression, coating, encapsulation, etc.) and associated systems.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations
onconformances/atypical events), ensuring clear problem statements, accurate timelines, and timely closure in the quality system.
Coordinate event triage and immediate actions, including containment and escalation, and support batch disposition decisions with Operations, Engineering, QC, and QA.
Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (e.g., batch records, equipment/maintenance logs, MES/SCADA/historian data, calibrations, environmental monitoring, and test results) to establish event sequence and contributing factors.
Facilitate cross-functional root cause analysis using structured tools (e.g., 5-Why, fishbone, fault tree as applicable) and document technically sound, compliant conclusions and product impact assessments.
Define, document, and track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on-the-floor verification and implementation to prevent recurrence.
Prepare clear, complete investigation/CAPA records; support trending and continuous improvement; and participate in audit/inspection readiness by providing evidence packages and responses (while maintaining required training and safe work practices).
#J-18808-Ljbffr
The role applies scientific and technical judgment to evaluate manufacturing and laboratory data, interviews and observation, equipment/utilities performance, and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g., blending, granulation, compression, coating, encapsulation, etc.) and associated systems.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations
onconformances/atypical events), ensuring clear problem statements, accurate timelines, and timely closure in the quality system.
Coordinate event triage and immediate actions, including containment and escalation, and support batch disposition decisions with Operations, Engineering, QC, and QA.
Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (e.g., batch records, equipment/maintenance logs, MES/SCADA/historian data, calibrations, environmental monitoring, and test results) to establish event sequence and contributing factors.
Facilitate cross-functional root cause analysis using structured tools (e.g., 5-Why, fishbone, fault tree as applicable) and document technically sound, compliant conclusions and product impact assessments.
Define, document, and track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on-the-floor verification and implementation to prevent recurrence.
Prepare clear, complete investigation/CAPA records; support trending and continuous improvement; and participate in audit/inspection readiness by providing evidence packages and responses (while maintaining required training and safe work practices).
#J-18808-Ljbffr