cGMP Deviation Investigation Consultants

The FDA Group; Indianapolis (IN); On-site; USD 96,000 - 152,000; Full time

Job summary

The FDA Group seeks two experienced cGMP Deviation Investigation Consultants to support a regulated pharmaceutical manufacturer in Indianapolis. The role focuses on aggressive backlog reduction while ensuring rigorous, compliant investigations with robust root cause analysis.

Responsibilities include leading investigations from data gathering to closure, coaching site personnel, and training teams on investigator qualifications. The engagement is primarily onsite with start ASAP.

Qualifications

• Demonstrated experience conducting and writing deviation investigations in a cGMP‑regulated manufacturing environment.
• Previous experience performing cGMP inspections.
• Strong root cause investigation and problem‑solving capabilities.
• Experience investigating manufacturing events such as equipment failures, human error, and failure to follow procedures.
• Ability to independently drive investigations from information gathering through documented conclusion and closure.
• Strong written documentation skills with the ability to produce clear, defensible investigation records.
• Ability to work collaboratively with manufacturing and quality personnel in an onsite environment.
• Ability to coach or train personnel on effective investigation and root cause analysis practices.

Responsibilities

• Write, manage, and drive manufacturing deviation investigations through completion and closure.
• Investigate events involving equipment failures, human error, procedural noncompliance, and other manufacturing‑related deviations.
• Conduct thorough root cause investigations in accordance with applicable cGMP expectations.
• Gather and evaluate relevant information from manufacturing personnel, records, procedures, equipment documentation, and other investigation sources.
• Develop clear, technically sound investigation narratives, conclusions, and supporting documentation based on objective evidence.
• Help reduce the backlog of open and overdue investigations while maintaining investigation quality and compliance.
• Work directly with site personnel and responsible stakeholders to obtain information, resolve investigation gaps, and support timely closure.
• Provide practical coaching and training to site personnel on effective investigation and root cause analysis practices.
• Support development of stronger internal investigation capabilities as the site implements an investigator qualification program.
• Apply prior cGMP inspection experience to identify investigation weaknesses and promote practices aligned with regulatory expectations.

Skills

cGMP investigations

Root cause analysis

Investigations writing

Onsite collaboration

Coaching/training

Regulatory compliance

Job description

cGMP Deviation Investigation Consultants

Location: Indianapolis, Indiana
Work Arrangement: Primarily Onsite
Duration: Approximately 3–6 months
Openings: 2 Consultants
Start: ASAP
Schedule: Full-time

Position Overview

We are seeking two experienced cGMP Deviation Investigation Consultants to support a regulated pharmaceutical manufacturing organization in Indiana.

The consultants will provide hands‑on support addressing a significant backlog of open and overdue manufacturing investigations. The primary objective is to accelerate investigation completion and closure while ensuring investigations are thorough, compliant, technically sound, and supported by appropriate root cause analysis.

In addition to executing investigations, the consultants will help strengthen site investigation capabilities by coaching and training personnel on effective root cause investigation practices as the organization implements an investigator qualification program.

Key Responsibilities

• Write, manage, and drive manufacturing deviation investigations through completion and closure.

• Investigate events involving equipment failures, human error, procedural noncompliance, and other manufacturing‑related deviations.

• Conduct thorough root cause investigations in accordance with applicable cGMP expectations.

• Gather and evaluate relevant information from manufacturing personnel, records, procedures, equipment documentation, and other investigation sources.

• Develop clear, technically sound investigation narratives, conclusions, and supporting documentation based on objective evidence.

• Help reduce the backlog of open and overdue investigations while maintaining investigation quality and compliance.

• Work directly with site personnel and responsible stakeholders to obtain information, resolve investigation gaps, and support timely closure.

• Provide practical coaching and training to site personnel on effective investigation and root cause analysis practices.

• Support development of stronger internal investigation capabilities as the site implements an investigator qualification program.

• Apply prior cGMP inspection experience to identify investigation weaknesses and promote practices aligned with regulatory expectations.

Required Qualifications

• Demonstrated experience conducting and writing deviation investigations in a cGMP‑regulated manufacturing environment.

• Previous experience performing cGMP inspections.

• Strong root cause investigation and problem‑solving capabilities.

• Experience investigating manufacturing events such as equipment failures, human error, and failure to follow procedures.

• Ability to independently drive investigations from information gathering through documented conclusion and closure.

• Strong written documentation skills with the ability to produce clear, defensible investigation records.

• Ability to work collaboratively with manufacturing and quality personnel in an onsite environment.

• Ability to coach or train personnel on effective investigation and root cause analysis practices.

Work Arrangement

The engagement is expected to begin with significant onsite support in the Indianapolis area so the consultants can understand site operations, become familiar with the facility, and work directly with responsible personnel. The role is expected to remain primarily onsite, particularly during the early stages of the engagement.

Ideal Candidate

The ideal consultant is an experienced cGMP investigation professional who can immediately provide hands‑on support for a high‑volume investigation backlog while also helping strengthen the organization’s long‑term investigation capabilities through practical coaching and training.