GMP Deviation Investigator | Hybrid QA Consultant

Pioneer GMP Consulting; Bloomington (IN); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Life insurance

Travel reimbursements

Job summary

Pioneer GMP Consulting is seeking a QA Consultant to actively lead GMP deviation investigations in a sterile manufacturing setting. You will work as a full‑time W2 employee supporting a Bloomington, IN client with a hybridRemote schedule.

Responsibilities include leading investigations, collecting evidence, performing root cause analyses, developing CAPAs, and writing defensible reports while coaching client investigators and ensuring inspection readiness.

Qualifications

• 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 remotely from within the United States approximately three weeks per month.
• Ability to work onsite in Bloomington, Indiana, approximately one week per month.
• Ability to support additional onsite time during onboarding, training, investigator qualification, or periods of increased client need.
• Ability to begin employment within approximately two weeks.
• Authorization to work in the United States without current or future sponsorship

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 established quality and closure timelines.
• Gather and evaluate evidence through interviews, document review, data analysis, process observation, and collaboration with subject‑matter experts.
• Develop clear problem statements, investigation plans, timelines, event chronologies, and evidence‑based conclusions.
• Perform thorough 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 the client’s procedures, priorities, workflows, documentation standards, and reporting structure.
• Provide hands‑on coaching and mentorship to client investigators.
• Strengthen investigator capabilities in root cause analysis, impact assessment, CAPA development, evidence evaluation, 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, findings, risks, constraints, and recommendations clearly 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 a commitment to client success

Skills

Quality Assurance

GMP deviation investigations

Sterile manufacturing

Root cause analysis

CAPA development

Technical writing

cGMP knowledge

Regulatory expectations

Interviewing

Tools

Quality Management Systems

Job description

Pioneer GMP Consulting is seeking a QA Consultant to actively lead GMP deviation investigations in a sterile manufacturing setting. You will work as a full‑time W2 employee supporting a Bloomington, IN client with a hybridRemote schedule.

Responsibilities include leading investigations, collecting evidence, performing root cause analyses, developing CAPAs, and writing defensible reports while coaching client investigators and ensuring inspection readiness.