Quality Investigations Lead — CAPA & GMP Excellence

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 83,000 - 131,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a Technical Operations Investigation Contractor to oversee investigations into deviations and quality events in a GMP-regulated setting. You will gather data, interview staff, and apply root-cause methodologies to identify true causes and craft CAPA plans.

Responsibilities include leading cross-functional investigations, ensuring timely completion, and maintaining meticulous documentation in TrackWise and Veeva contexts.

Qualifications

• Experience conducting investigations in GMP-regulated environments.
• Strong technical writing and documentation skills are required.
• Ability to interpret data, trends and process performance indicators.

Responsibilities

• Lead end-to-end investigations for deviations and quality events.
• Gather and analyze data, interview personnel, and review documentation to understand event details.
• Apply structured root-cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone, Fault Tree).
• Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
• Identify true root causes supported by evidence and develop CAPA plans.

Skills

GMP/GDP knowledge

Technical writing

Data interpretation

Communication skills

Multi-tasking

Education

BS in engineering, chemistry, biology or life science related field

Tools

TrackWise

Veeva

Job description

Biopharma-Consulting-Jad-Group seeks a Technical Operations Investigation Contractor to oversee investigations into deviations and quality events in a GMP-regulated setting. You will gather data, interview staff, and apply root-cause methodologies to identify true causes and craft CAPA plans.

Responsibilities include leading cross-functional investigations, ensuring timely completion, and maintaining meticulous documentation in TrackWise and Veeva contexts.