QA - Compliance Investigator

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.

Job Description QA Consultant - GMP Deviation Investigations | Sterile Manufacturing

Job Type : Full-Time

Start Date: As soon as possible; Schedule: Full-time
About the Opportunity 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.
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.
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.
What You'll Do Serve as a Pioneer QA Consultant supporting the client’s GMP deviation investigation program
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
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
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
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
Qualifications 5+ years of Quality Assurance or related pharmaceutical or biotechnology industry experience
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 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 work effectively with stakeholders across Quality, Manufacturing, Engineering, Validation, and Technical Operations
Ability to meet the position’s onsite and travel requirements
What Will Set You Apart 10+ years of pharmaceutical or biotechnology Quality Assurance experience

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
Proven ability to deliver high-quality results independently in a fast-paced consulting environment
Travel reimbursement and related expenses may apply depending on engagement requirements.
Pioneer GMP Consulting provides quality, compliance, validation, and operational support to pharmaceutical, biotechnology, and life sciences organizations.
They are supported by Pioneer’s leadership and network of industry experts while working directly alongside client teams to solve complex GMP challenges, strengthen quality systems, and support sustainable compliance.
We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.

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