Quality Control Investigator
Jobs via Dice, Florida, NY, United States
Position
Quality Control Investigator
Location & Work Details
Location: Davie, FL (Onsite)
Work Hours: Monday – Friday, 40 hours
Shift: 1st Shift (8:00 AM – 5:00 PM)
Responsibilities
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, track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on‑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).
Job Requirements
Master’s or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories; oral solid dosage (OSD) experience preferred.
Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred.
Solid understanding of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness.
Skills Required
OSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities).
Strong technical writing and documentation skills (deviations
onconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP).
Analytical and problem‑solving capability using structured root‑cause analysis tools (e.g., 5‑Why, fishbone, fault tree) to separate symptoms from true root causes.
Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., eQMS, MES, LIMS, historian/trending tools, Excel/dashboards) to support risk‑based decisions.
Effective cross‑functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and clearly presenting complex technical information.
Problem Solving Approach
Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires analysis of situations or data and an in‑depth knowledge and evaluation of various known and unknown factors.
Seeks out all resources when selecting methods and techniques for obtaining results.
Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
Able to identify solutions to general problems through collaboration and creativity.
Salary & Benefits
Listed salary ranges may vary based on experience, qualifications, and local market. Salary may also include bonuses or other incentives.
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Quality Control Investigator
Location & Work Details
Location: Davie, FL (Onsite)
Work Hours: Monday – Friday, 40 hours
Shift: 1st Shift (8:00 AM – 5:00 PM)
Responsibilities
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, track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on‑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).
Job Requirements
Master’s or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories; oral solid dosage (OSD) experience preferred.
Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred.
Solid understanding of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness.
Skills Required
OSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities).
Strong technical writing and documentation skills (deviations
onconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP).
Analytical and problem‑solving capability using structured root‑cause analysis tools (e.g., 5‑Why, fishbone, fault tree) to separate symptoms from true root causes.
Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., eQMS, MES, LIMS, historian/trending tools, Excel/dashboards) to support risk‑based decisions.
Effective cross‑functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and clearly presenting complex technical information.
Problem Solving Approach
Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires analysis of situations or data and an in‑depth knowledge and evaluation of various known and unknown factors.
Seeks out all resources when selecting methods and techniques for obtaining results.
Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
Able to identify solutions to general problems through collaboration and creativity.
Salary & Benefits
Listed salary ranges may vary based on experience, qualifications, and local market. Salary may also include bonuses or other incentives.
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