Catalent · 7 hours ago
Compliance Specialist
Lawrenceburg, IN
Full-time
Onsite
Mid Level
3+ years expCatalent is a global leader in drug development and delivery, and they are seeking a Compliance Specialist to support and maintain quality and regulatory compliance at their Greendale facility. The role involves overseeing quality systems, supporting audits, and driving continuous improvement in compliance and documentation.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Oversee and execute JDE administrative tasks for QA, including master data management for the Greendale site
Coordinate new material setup for the Greendale site
Support supplier quality processes, collaborating with the Corporate Quality team on TrackWise deployments (Internal Audit, External Audit, SQM, CAPA, QCA modules)
Coordinate creation and maintenance of internal specifications for all materials including (raw materials, packaging materials, etc.)
Support regulatory and certification audits (e.g., SQF, NSF, QAI) and ensure audit readiness
Assist with review/revision of the Food Safety Plan and HACCP, focusing on raw material requirements/compliance
Collaborate and support documentation of raw material risk assessments and supplier documentation (forms, certifications, etc.)
Follow up on site improvement actions to address compliance gaps
Support maintenance and updates of site regulatory documents as needed
Other duties assigned
Qualification
Required
Bachelor's degree in a scientific, engineering, or technical discipline (or equivalent experience) required
Preferred
3+ years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred)
Experience with quality systems, supplier quality management, and electronic systems such as TrackWise
Familiarity with regulatory audit processes (SQF, NSF, FDA, etc.) and food safety programs (HACCP)
Working knowledge of regulatory and certification standards/requirements and practical application
Internal/external auditing experience
Experience with JDE or similar ERP systems
Knowledge of risk assessment methodologies and supplier management best practices
Occasional lifting (up to 30 lbs), sitting, standing, and use of computer equipment
Must be able to work on-site during standard business hours, with occasional overtime as needed
Benefits
152 hours of PTO + 8 Paid Holidays
Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
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