Quality Investigator — NCRs, CAPA & Root Cause

Sharp Services; Bethlehem (Northampton County); On-site; USD 65,000 - 95,000; Full time

Job summary

Sharp Services seeks an Investigator to lead and document investigations relating to non-conformances and complaints at Sharp Clinical sites. The role applies root cause analysis to determine contributing factors and to design CAPAs for prevention, collaborating with internal and external stakeholders.

The Investigator will drive containment actions, improve processes, and support GMP training and quality systems, ensuring timely, accurate reporting and cross-functional coordination.

Qualifications

• Experience leading investigations into non-conformances and complaints.
• Ability to apply root cause analysis tools and CAPA design.
• Strong written communication and documentation skills.
• Collaborative approach with QA, production and training teams.

Responsibilities

• Lead investigations into non-conformances and complaints with timely completion.
• Document investigation findings and root-cause analysis in the corresponding QMS.
• Develop corrective and preventive actions (CAPAs) and monitor effectiveness.
• Collaborate with SME and operations to implement process improvements.
• Support GMP training programs and related SOPs.
• Provide training input to improve issue prevention and containment.
• Adapt to changing priorities and deadlines while maintaining quality.
• Produce clear, detailed investigation reports for QualityOne (QMS).
• Assist in other quality management activities as needed.

Job description

Sharp Services seeks an Investigator to lead and document investigations relating to non-conformances and complaints at Sharp Clinical sites. The role applies root cause analysis to determine contributing factors and to design CAPAs for prevention, collaborating with internal and external stakeholders.

The Investigator will drive containment actions, improve processes, and support GMP training and quality systems, ensuring timely, accurate reporting and cross-functional coordination.