Biomanufacturing Compliance Investigator – Deviations

Catalent Pharma Solutions; Madison (WI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Competitive PTO + 8 holidays

Medical, dental, and vision benefits (

Tuition reimbursement

Diversity, inclusive culture

Job summary

Catalent Pharma Solutions in Madison, WI seeks an Associate Lead I – Biomanufacturing Compliance, Investigator - Deviations. You will author and revise deviation records and CGMP documents, support audits, and participate in inspection readiness.

The role emphasizes cGMP knowledge, Root Cause Analysis, CAPA implementation, and collaboration across manufacturing and quality teams; shift Mon-Fri 9am-4pm onsite.

Qualifications

• High School Diploma or GED with at least 4+ years of related experience, or an Associate’s degree in STEM with 1+ years of related experience.
• No experience required with a Bachelor’s degree in a STEM‑related field.
• 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®.

Responsibilities

• Author and revise deviation records, preventative actions, and related cGMP documents under minimal supervision in a timely manner.
• Develop familiarity with upstream, downstream, materials management, production facility, systems, and technologies to ensure accurate completion of responsibilities.
• Track and monitor open investigations, providing timely and accurate status updates.
• Engage in initiatives to improve process compliance culture, including ongoing cGMP understanding and application.
• 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.

Skills

Deviation writing

Root Cause Analysis

CAPA implementation

Quality systems knowledge

Education

Bachelor’s degree in STEM

Associate’s degree in STEM

Tools

TrackWise®

ComplianceWire®

JD Edwards®

Unicorn®

Microsoft Office

Job description

Catalent Pharma Solutions in Madison, WI seeks an Associate Lead I – Biomanufacturing Compliance, Investigator - Deviations. You will author and revise deviation records and CGMP documents, support audits, and participate in inspection readiness.

The role emphasizes cGMP knowledge, Root Cause Analysis, CAPA implementation, and collaboration across manufacturing and quality teams; shift Mon-Fri 9am-4pm onsite.