Quality Investigations Lead – Technical Ops (Contract)

BioPharma Consulting JAD Group; Boston, Northern (MA, KY); Hybrid; USD 55,000 - 83,000; Part time

Job summary

BioPharma Consulting JAD Group in Boston is seeking a Technical Operations Investigation Contractor to oversee, conduct, and document investigations into deviations and quality events, driving true root causes and CAPA actions. You will systematically gather data, interview personnel, and review records to ensure timely, compliant conclusions.

The role demands strong analytical skills, robust technical writing, and collaboration across Operations, Quality Assurance, Engineering, and Maintenance

Qualifications

• BS in engineering, chemistry, biology or life science related field.
• 2+ years of experience in investigations or quality events.
• Strong GMP/GDP knowledge and regulatory expectations.
• Excellent technical writing and documentation skills.

Responsibilities

• Lead end to end investigations for deviations and quality events.
• Gather and analyze data, interview personnel, and review documentation.
• Apply root cause analysis methods (e.g., 5 Why, Fishbone, Fault Tree).
• Ensure investigations meet timelines and regulatory standards.
• Develop CAPA plans addressing root causes and recurrence.
• Partner with process owners for CAPA implementation and closure.
• Prepare clear, compliant investigation reports.
• Maintain documentation in GMP-compliant systems.

Skills

GMP knowledge

GDP knowledge

Regulatory understanding

Technical writing

Data interpretation

Communication skills

Prioritization

Education

BS in engineering or life sciences

Tools

TrackWise

Veeva

Excel

Word

PowerPoint

Job description

BioPharma Consulting JAD Group in Boston is seeking a Technical Operations Investigation Contractor to oversee, conduct, and document investigations into deviations and quality events, driving true root causes and CAPA actions. You will systematically gather data, interview personnel, and review records to ensure timely, compliant conclusions.

The role demands strong analytical skills, robust technical writing, and collaboration across Operations, Quality Assurance, Engineering, and Maintenance