Technical Investigator – Quality & CAPA

West Pharmaceutical Services, Inc; Williamsport (Lycoming County); On-site; USD 65,000 - 90,000; Full time

Job summary

West Pharmaceutical Services, Inc is seeking a Technical Investigator in Williamsport, PA. The role leads investigations into manufacturing deviations, nonconformances, and quality events to protect product quality and regulatory compliance.

You will perform root cause analysis, review critical documentation, and support CAPA initiatives. Collaboration with QA, Manufacturing, Engineering, and Regulatory teams is essential for timely issue resolution.

Qualifications

• Minimum 3+ years’ work experience in medical/pharma manufacturing.
• Experience with quality investigations and CAPA processes.

Responsibilities

• Lead and support technical investigations related to deviations, nonconformances, complaints, process failures, and quality events.
• Perform root cause analyses using structured tools (8D, A3) and document findings clearly.
• Review batch records, device history records, and process data to support conclusions.
• Interviews with operators, technicians, engineers, and QA to gather accurate information.
• Assess risk to patient safety, product quality, and regulatory compliance.
• Develop, implement, and verify corrective and preventive actions.
• Collaborate across Manufacturing, QA, Engineering, Regulatory, Supply Chain, and Operations.

Skills

Root cause analysis

5 Whys

Fishbone

Data analysis

Statistics

Documentation

Communication

Education

Associate’s degree in engineering/quality/science

Tools

ISO 13485

21 CFR Part 820

EU GMP

Injection molding equipment

Job description

West Pharmaceutical Services, Inc is seeking a Technical Investigator in Williamsport, PA. The role leads investigations into manufacturing deviations, nonconformances, and quality events to protect product quality and regulatory compliance.

You will perform root cause analysis, review critical documentation, and support CAPA initiatives. Collaboration with QA, Manufacturing, Engineering, and Regulatory teams is essential for timely issue resolution.