QA Investigator (Bloomington, IN)

Pioneer GMP Consulting • Bloomington, IN

118d • Hybrid

About The Position

Pioneer GMP Consulting is seeking an experienced QA Consultant to support GMP deviation investigations for a pharmaceutical manufacturing client in Bloomington, Indiana. The role is a regular, full-time W2 position with Pioneer. The consultant will work closely with the client’s established investigation group, follow its procedures and reporting structure, and remain connected and accountable to Pioneer.

The consultant will independently manage a high volume of major and critical deviations from initiation through closure. The work requires direct Quality Assurance experience in sterile or aseptic pharmaceutical manufacturing, independent judgment, strong technical writing, and the ability to prepare complete, defensible, inspection-ready investigations with minimal ramp-up. The consultant will also coach client investigators and share practical practices for root cause analysis, impact assessment, CAPA development, evidence evaluation, and technical writing.

The initial client engagement is expected to last at least six months, with a strong possibility of extension. Pioneer employment is not limited to this engagement; Pioneer will work to identify future assignments aligned with the employee’s experience and capabilities, though future assignment timing and availability depend on client demand and are not guaranteed.

This is a hybrid consulting position involving recurring travel to Bloomington. The expected arrangement is approximately three weeks remote followed by approximately one week onsite each month. Additional onsite time may be needed for onboarding, training, investigator qualification, or increased client needs. The onsite schedule is a firm work requirement and will be coordinated with the client. The role requires authorization to work in the United States without current or future sponsorship. The candidate should be available to start within approximately two weeks.

Requirements

• At least five years of Quality Assurance or related experience in the pharmaceutical or biotechnology industry.
• Demonstrated experience independently leading major and critical GMP deviation investigations from initiation through closure.
• Direct Quality Assurance experience in sterile or aseptic pharmaceutical manufacturing.
• Experience managing multiple complex investigations in a high-volume 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 cGMP requirements, good documentation practices, data-integrity principles, and applicable regulatory expectations.
• Ability to evaluate complex manufacturing events, identify relevant evidence and contributing factors, and reach supportable conclusions.
• Ability to assess potential effects on product, process, equipment, facilities, utilities, and validated systems.
• 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 meet investigation closure timelines.
• Strong communication, collaboration, organization, interviewing, and problem-solving skills.
• Ability to work effectively with Quality, Manufacturing, Engineering, Validation, Technical Operations, and other stakeholders.
• Ability to work remotely from within the United States approximately three weeks per month.
• Ability to work onsite in Bloomington, Indiana, approximately one week per month, with additional onsite time as required for onboarding, training, investigator qualification, or client needs.
• Ability to begin employment within approximately two weeks.
• Authorization to work in the United States without current or future sponsorship.
• Ability to meet the onsite schedule and disclose any scheduling, location, or travel limitations during recruitment.

Nice To Haves

• Ten or more years of pharmaceutical or biotechnology Quality Assurance experience.
• Prior life sciences consulting or staff-augmentation experience.
• Experience investigating complex events involving sterile filling, aseptic processing, environmental monitoring, contamination control, sterility assurance, or other sterile manufacturing operations.
• Experience with major and critical investigations involving potential product or patient impact.
• Experience supporting regulatory remediation, consent-decree work, audit responses, or inspection-readiness initiatives.
• Experience working within a CDMO or supporting a CDMO client.
• Familiarity with electronic quality-management systems and deviation-management workflows.
• Experience coaching or mentoring investigators in root cause analysis, impact assessment, CAPA development, evidence evaluation, or technical writing.
• Ability to translate complex technical and compliance information into clear, practical, and defensible conclusions.
• Proven ability to deliver high-quality work independently in a fast-paced consulting environment.
• Ability to establish credibility quickly and influence outcomes without formal authority.
• Strong consulting mindset and ability to remain accountable to both the client and Pioneer.
• Professionalism, adaptability, responsiveness, sound judgment, and commitment to Pioneer’s long-term success.

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 concurrent investigations while meeting quality and closure timelines.
• Gather and evaluate evidence through interviews, document review, data analysis, process observation, and collaboration with subject-matter experts.
• Develop problem statements, investigation plans, timelines, event chronologies, and evidence-based conclusions.
• Perform root cause analyses using appropriate investigation tools and methodologies.
• Distinguish root causes from contributing factors and unsupported assumptions.
• Assess potential effects on product quality, patient safety, manufacturing processes, equipment, facilities, utilities, validated systems, and quality systems.
• Evaluate batch, product, process, and compliance impact using documented evidence and sound Quality judgment.
• Develop corrective and preventive actions that address identified causes and reduce recurrence risk.
• Write clear, technically sound, defensible, and inspection-ready investigation reports.
• Identify investigation gaps, weak conclusions, unsupported causal statements, and ineffective CAPAs.
• Collaborate with Quality, Manufacturing, Engineering, Validation, Technical Operations, and other client functions.
• Follow client procedures, priorities, workflows, documentation standards, and reporting structure.
• Coach and mentor client investigators, strengthening their capabilities in root cause analysis, impact assessment, CAPA development, evidence evaluation, and technical writing.
• Complete required client training and investigator-qualification activities.
• Support deviation trending, regulatory remediation, audit support, and inspection-readiness activities as needed.
• Communicate investigation status, findings, risks, constraints, and recommendations to client and Pioneer stakeholders.
• Escalate significant quality, compliance, product, or schedule concerns appropriately.
• Maintain accurate, complete, traceable, and inspection-ready documentation.
• Represent Pioneer with professionalism, credibility, accountability, and commitment to client success.

Benefits

• Medical insurance, with Pioneer currently contributing 50% of employee premiums, for eligible regular, full-time employees.
• Dental insurance for eligible regular, full-time employees.
• Vision insurance for eligible regular, full-time employees.
• $100,000 basic life insurance for eligible regular, full-time employees.
• 401(k) retirement plan for eligible regular, full-time employees.
• Direct access to Pioneer leadership.
• Opportunities to support high-impact client engagements.
• Approved engagement-related travel expenses reimbursed in accordance with applicable Pioneer and client policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed