QA Investigator (Bloomington, IN)
HybridBloomington, Indiana, United States
Job Summary
Independently lead major and critical GMP deviation investigations from initiation through closure for a sterile manufacturing client. Manage multiple investigations simultaneously while gathering data via interviews, document review, and process observation to perform thorough root cause analyses. Develop corrective and preventive actions, write inspection-ready reports, and provide hands-on coaching to client investigators on root cause methodology and CAPA development. Collaborate with Quality, Manufacturing, and Engineering teams to assess impacts and support regulatory remediation and audit readiness. Operate onsite approximately one week per month with a minimum six-month duration.
Required Qualifications
- 5+ years of Quality Assurance or related pharmaceutical or biotechnology industry experience
- Demonstrated experience independently leading major and critical GMP deviation investigations from initiation through closure
- Direct Quality Assurance experience within a sterile or aseptic pharmaceutical manufacturing environment
- Strong knowledge of root cause analysis, product and process impact assessment, and CAPA development
- Excellent technical writing skills, including experience producing clear, defensible, and inspection-ready investigation reports
- Strong working knowledge of current Good Manufacturing Practices and applicable regulatory requirements
- Ability to evaluate complex manufacturing events, identify contributing factors, and reach evidence-based conclusions
- Ability to apply sound, independent quality judgment in a client-facing consulting environment
- Ability to learn client procedures and investigation workflows quickly and contribute with limited supervision
- Ability to manage competing priorities and multiple investigations in a high-volume manufacturing environment
- Strong communication, collaboration, organization, and problem-solving skills
- Ability to work effectively with stakeholders across Quality, Manufacturing, Engineering, Validation, and Technical Operations
- Ability to meet the position's onsite and travel requirements
- Must be authorized to work in the United States; sponsorship is not available
Desired Qualifications
- 10+ years of pharmaceutical or biotechnology Quality Assurance experience
- Strong consulting mindset with the ability to represent Pioneer effectively while integrating into a client team
- Experience investigating complex events involving sterile filling, aseptic processing, environmental monitoring, contamination control, or other sterile manufacturing operations
- Experience supporting regulatory remediation, audit responses, or inspection-readiness activities
- Experience working within a contract development and manufacturing organization
- Familiarity with electronic quality management systems and deviation-management workflows
- Experience coaching or mentoring investigators in root cause analysis, impact assessment, CAPA development, or technical writing
- Ability to translate complex technical and compliance information into clear, practical, and defensible conclusions
- Proven ability to deliver high-quality results independently in a fast-paced consulting environment
- Ability to build strong relationships with both client and Pioneer colleagues
- Professionalism, adaptability, accountability, and commitment to Pioneer's success across client engagements
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