Technical Investigator - Quality & CAPA Leadership

West Pharmaceutical Services; Williamsport (Lycoming County); On-site; USD 70,000 - 110,000; Full time

Job summary

West Pharmaceutical Services in Williamsport, PA, seeks a Technical Investigator to lead investigations into manufacturing deviations, nonconformances, and quality events within a medical device environment. You will conduct root cause analysis, review records, and support CAPAs to ensure product quality and regulatory compliance.

Collaborating with Manufacturing, QA, Engineering, and Regulatory teams, you will document findings, ensure timely completion, and uphold Good Documentation Practices

Qualifications

• Knowledge of ISO 13485 and 21 CFR Part 820 applicable to medical devices.
• Strong root-cause analysis and problem-solving skills (8D, A3).
• Experience with process mapping, statistics, and data-driven investigations.
• Ability to clearly document investigations and CAPA actions.

Responsibilities

• Lead investigations into manufacturing deviations, nonconformances, and quality events.
• Conduct thorough root cause analysis using structured tools (5 Whys, Fishbone, 8D).
• Review batch records and equipment logs to support conclusions.
• Interview operators and engineers to gather accurate information for investigations.
• Document findings in compliance with regulatory requirements and internal procedures.
• Support CAPA development, implementation, and verification across functions.

Skills

Root cause analysis

8D problem solving

Statistics & data analysis

Quality systems awareness

Technical writing

Education

Associate's degree in engineering

Job description

West Pharmaceutical Services in Williamsport, PA, seeks a Technical Investigator to lead investigations into manufacturing deviations, nonconformances, and quality events within a medical device environment. You will conduct root cause analysis, review records, and support CAPAs to ensure product quality and regulatory compliance.

Collaborating with Manufacturing, QA, Engineering, and Regulatory teams, you will document findings, ensure timely completion, and uphold Good Documentation Practices