Biomanufacturing Compliance Investigator – Deviations

Catalent Pharma Solutions; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

8 paid holidays

Competitive PTO

Job summary

Catalent’s Madison, Wisconsin site seeks an Associate Lead I – Biomanufacturing Compliance, Investigator - Deviations to author and revise deviation records and cGMP documents. You will partner with manufacturing and quality teams, support audits, and participate in inspection readiness activities, ensuring timely updates and sustained compliance.

The role is 100% onsite in Madison, WI. Qualified candidates have 4+ years in deviation writing, Root Cause Analysis, and CAPA implementation, with

Qualifications

• High School Diploma or GED with 4+ years of related experience, or an Associate’s degree in STEM with 1+ years of related experience.
• Experience in deviation writing and with Root Cause Analysis and Corrective and Preventive Action implementation.
• Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®.
• Ability to apply cGMP principles and best practices to ensure compliant, high‑quality execution of procedures.
• Foundational knowledge of manufacturing and laboratory operations, with the ability to learn new processes and techniques.
• Experience with deviation investigations, including corrective and preventive actions.
• Experience authoring and editing Standard Operating Procedures and related documentation under guidance.

Responsibilities

• Author and revise deviation records, preventative actions, and related cGMP documents under minimal supervision.
• Develop familiarity with upstream, downstream, materials management, production facility, systems, and technologies.
• Track and monitor open investigations, providing timely status updates.
• Engage in initiatives to improve process compliance culture and cGMP understanding.
• Actively participate in Inspection Readiness activities and teams.
• Provide guidance to write and revise Standard Operating Procedures when gaps are identified.
• Assist in supporting internal and client audits as needed.
• Exhibit professional behavior reflecting company policies.

Skills

Deviation writing

Root Cause Analysis

CAPA implementation

TrackWise

Compliance awareness

JD Edwards

Unicorn

Microsoft Office

Quality systems

cGMP principles

Education

High School Diploma or GED

Associate’s degree in STEM

Bachelor’s degree in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

Catalent’s Madison, Wisconsin site seeks an Associate Lead I – Biomanufacturing Compliance, Investigator - Deviations to author and revise deviation records and cGMP documents. You will partner with manufacturing and quality teams, support audits, and participate in inspection readiness activities, ensuring timely updates and sustained compliance.

The role is 100% onsite in Madison, WI. Qualified candidates have 4+ years in deviation writing, Root Cause Analysis, and CAPA implementation, with