QA Investigator (Bloomington, IN)

QA Consultant – GMP Deviation Investigations | Sterile Manufacturing

Job Type: Regular, Full-Time W2 Hourly Employee

Location: Bloomington, Indiana

Work Arrangement: Approximately Three Weeks Remote and One Week Onsite per Month

Schedule: Full-Time

Start Date: As Soon as Possible; Candidates Should Be Available to Start Within Approximately Two Weeks

Initial Engagement: Minimum of Six Months, with a Strong Possibility of Extension

Employment Type: W2 Employee of Pioneer GMP Consulting

Work Authorization: Must Be Authorized to Work in the United States; Sponsorship Is Not Available

Candidate Deck: QA Consultant – GMP Deviation Investigations

About the Opportunity

Pioneer GMP Consulting is seeking an experienced QA Consultant to support GMP deviation investigations for a pharmaceutical manufacturing client in Bloomington, Indiana.

You will join Pioneer as a regular, full-time W2 employee while working closely with the client’s established investigation group. You will serve as a trusted Quality partner, integrating into the client’s procedures, priorities, workflows, and reporting structure while remaining connected and accountable to Pioneer.

You will independently manage a high volume of major and critical deviations from initiation through closure. This role requires direct Quality Assurance experience in sterile or aseptic pharmaceutical manufacturing, sound independent judgment, excellent technical writing, and the ability to produce complete, defensible, and inspection-ready investigations with minimal ramp-up time.

In addition to leading investigations, you will 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.

The initial client engagement is expected to last at least six months, with a strong possibility of extension. Employment with Pioneer is not intended to be limited to one client engagement. When an engagement concludes, Pioneer will work to identify another opportunity aligned with your experience and capabilities; however, the timing and availability of future assignments depend on client demand and cannot be guaranteed.

What You’ll Do

• 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

Required 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 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

• 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

What Will Set You Apart

• 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

Work Arrangement and Travel

This is a full-time hybrid consulting position with recurring travel to Bloomington, Indiana.

The current arrangement is expected to include approximately three weeks of remote work followed by approximately one week onsite each month. Additional onsite time will be required during onboarding, client training, investigator qualification, and potentially at other times based on client needs.

The onsite schedule will be coordinated with the client and should be treated as a firm work requirement. Candidates must disclose any scheduling, location, or travel limitations during the recruiting process.

Future Pioneer assignments may have different locations, schedules, work arrangements, responsibilities, or travel requirements.

Compensation and Benefits

Employment Type: Regular, full-time W2 hourly employee of Pioneer GMP Consulting

Compensation Range: Compensation is determined based on experience, technical expertise, engagement requirements, and other job-related factors.

Eligible regular, full-time employees may receive:

• Medical insurance, with Pioneer currently contributing 50% of employee premiums

• Dental insurance

• Vision insurance

• $100,000 basic life insurance

• 401(k) retirement plan

• Direct access to Pioneer leadership

• Opportunities to support high-impact client engagements

Approved travel expenses associated with the engagement will be reimbursed in accordance with applicable Pioneer and client policies.

Benefits are subject to eligibility requirements and applicable plan documents. Benefit offerings may change over time.

About Pioneer GMP Consulting

Pioneer GMP Consulting provides quality, compliance, validation, engineering, regulatory, technology, and operational support to pharmaceutical, biotechnology, and life sciences organizations.

Our consultants are members of the Pioneer team—not simply resources assigned to a client. 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 apply critical thinking, Lean GMP principles, and practical solutions to evolve traditional GMP practices. We value not only technical expertise, but also how our consultants communicate, collaborate, solve problems, build relationships, and represent Pioneer.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable federal, state, or local law.