Biomanufacturing Compliance Lead I - Night Shift (GMP)

Catalent; Madison (WI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits (

Tuition Reimbursement

Paid time off & holidays

Day-one benefits availability

Job summary

Catalent in Madison, Wisconsin, seeks an Associate Lead I - Biomanufacturing, Compliance to support cGMP manufacturing operations and ensure adherence to SOPs and regulatory requirements. This role helps maintain quality and drives continuous improvement in a high‑performing team.

The position emphasizes thorough deviation investigations, internal audits, CAPA implementation, and ongoing cGMP training, with a 100% onsite schedule on a night shift.

Qualifications

• Requires knowledge of cGMP principles and quality systems.
• Experience with deviation investigations and CAPAs.
• Ability to author and edit SOPs and related documentation.

Responsibilities

• Facilitate Rapid Response Team when deviations occur and document root cause data.
• Review logbooks for cGMP compliance and track investigations.
• Support internal audits and assist in corrective actions.
• Identify training needs and communicate policies affecting GMP.
• Assist in SOP creation for new processes or technologies.
• Contribute to safety improvements and provide floor support.
• Participate in CAPA programs and ongoing cGMP training.
• Perform other duties as assigned.

Skills

cGMP knowledge

CAPA & deviation

SOP writing

Data review

Microsoft Office

Education

High School Diploma

Associate’s degree in STEM

Bachelor’s degree in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

Catalent in Madison, Wisconsin, seeks an Associate Lead I - Biomanufacturing, Compliance to support cGMP manufacturing operations and ensure adherence to SOPs and regulatory requirements. This role helps maintain quality and drives continuous improvement in a high‑performing team.

The position emphasizes thorough deviation investigations, internal audits, CAPA implementation, and ongoing cGMP training, with a 100% onsite schedule on a night shift.