GMP Investigations Lead for CAPA & Quality

Adare Pharma Solutions; Vandalia (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Adare Pharma Solutions is seeking an Investigations Supervisor in Vandalia, OH to oversee manufacturing investigations related to deviations, non-conformances, batch discrepancies, equipment failures and GMP events. This role provides day-to-day leadership to the investigations team and ensures scientifically sound, compliant investigations.

You will collaborate with Manufacturing, Quality, Engineering, Validation, QC, MS&T and Supply Chain to drive root-cause determinations, CAPA

Qualifications

• Bachelor’s degree with at least 1 year of leadership experience and 4+ years in the pharmaceutical industry.
• Experience leading investigations and implementing CAPAs.
• Experience with deviation management, non-conformance investigations, change control, and quality systems activities.

Responsibilities

• Supervise and coordinate investigations related to deviations, non-conformances, batch discrepancies, process failures, equipment malfunctions, material discrepancies, environmental excursions, and GMP-related events.
• Provide leadership and guidance to investigators, ensuring investigations are completed accurately and within established timelines.
• Partner with cross-functional departments (Manufacturing, Quality, Engineering, Validation, QC, MS&T, Supply Chain) to gather data and assess impact.
• Review investigation reports for accuracy, completeness, and regulatory compliance.
• Facilitate root cause analyses using 5 Whys, Ishikawa diagrams, process mapping, human factors analysis, and equipment troubleshooting.
• Lead investigations through closure with containment actions, root cause determination, and CAPA implementation.
• Collaborate with process owners to develop and implement CAPAs addressing root causes and recurrence.
• Support and maintain Manufacturing Quality Systems including CAPA, Change Control, deviation management, and NCR programs.
• Develop and maintain departmental metrics and dashboards to measure investigation performance and effectiveness.
• Support continuous improvement by identifying weaknesses and recommending procedural or equipment enhancements.
• Review, revise, and approve SOPs and quality documentation related to manufacturing investigations.
• Maintain visibility on the manufacturing floor to observe operations and support real-time investigations.
• Assist with internal and customer audits and regulatory inspections by presenting investigation documentation and CAPA data.

Skills

Leadership experience

Investigations

CAPA implementation

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Job description

Adare Pharma Solutions is seeking an Investigations Supervisor in Vandalia, OH to oversee manufacturing investigations related to deviations, non-conformances, batch discrepancies, equipment failures and GMP events. This role provides day-to-day leadership to the investigations team and ensures scientifically sound, compliant investigations.

You will collaborate with Manufacturing, Quality, Engineering, Validation, QC, MS&T and Supply Chain to drive root-cause determinations, CAPA