QA Investigator (Bloomington, IN)

Pioneer GMP Consulting•Bloomington, IN

9d•Hybrid

About The Position

We’re seeking an experienced QA Consultant to join the Pioneer GMP Consulting team and support GMP deviation investigations for a pharmaceutical manufacturing client in Bloomington, Indiana. As a Pioneer consultant, you’ll be an important member of our team while working closely with the client’s established investigation group. You’ll have the support of Pioneer’s leadership and internal network of quality and compliance experts throughout the engagement. At the client site, you’ll serve as a trusted quality partner—integrating into the client’s processes and reporting structure while representing Pioneer’s standards, values, and commitment to quality. You’ll independently manage a high volume of major and critical deviations from initiation through closure. This role requires strong experience in sterile or aseptic manufacturing, sound quality judgment, and the ability to produce clear, technically defensible, and inspection-ready investigation reports with minimal ramp-up. In addition to leading investigations, you’ll help strengthen the client’s internal capabilities by coaching investigators and sharing practical best practices related to root cause analysis, impact assessment, CAPA development, and technical writing.

Requirements

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

Nice To Haves

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

Responsibilities

Serve as a Pioneer QA Consultant supporting the client’s GMP deviation investigation program
Independently lead major and critical GMP deviation investigations from initiation through closure
Manage multiple investigations simultaneously while meeting established quality and closure timelines
Gather and evaluate information through interviews, document review, data analysis, process observation, and collaboration with subject matter experts
Perform thorough root cause analyses using appropriate investigation tools and methodologies
Assess potential impacts to products, processes, equipment, facilities, utilities, and quality systems
Develop appropriate corrective and preventive actions that address identified root causes and reduce recurrence risk
Write clear, technically sound, defensible, and inspection-ready investigation reports
Apply sound quality judgment when evaluating investigation findings, product impact, compliance risk, and proposed CAPAs
Collaborate with Quality, Manufacturing, Engineering, Validation, Technical Operations, and other client functions
Integrate into the client’s investigation team while remaining actively connected to Pioneer’s team, leadership, and quality expectations
Follow established client procedures, priorities, workflows, and reporting structures
Provide hands-on coaching and mentorship to client investigators
Share investigation best practices and strengthen capabilities in root cause analysis, impact assessment, CAPA development, and technical writing
Complete all required client training and investigator qualification activities
Support deviation trending, regulatory remediation, audit support, and inspection-readiness activities as needed
Communicate investigation status, risks, findings, and recommendations clearly to client and Pioneer stakeholders
Represent Pioneer with professionalism, credibility, accountability, and a commitment to client success