QA Investigator; Bloomington

Bloomington, United States | Posted on 07/16/2026

Pioneer GMP Consulting is a specialized life sciences consultancy focused on delivering high-impact GMP compliance, validation, and quality system solutions to biopharmaceutical clients. We support startups, CDMOs, and global manufacturers across the product lifecycle, from clinical-stage development to commercial readiness.

QA Consultant – GMP Deviation Investigations | Sterile Manufacturing

Job Type :
Full-Time

Duration: Minimum of six months, with a strong possibility of extension

Start Date: As soon as possible; candidates should be available to start within two weeks

Schedule: Full-time

Onsite Expectations: Approximately one week onsite per month, with additional onsite time required during onboarding and qualification

Work Authorization: Must be authorized to work in the United States; sponsorship is not available

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.

• 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

• 5+ years of Quality Assurance or related pharmaceutical or biotechnology…