Compliance Specialist

Catalent • Greendale, IN

8h • Onsite

About The Position

Compliance Specialist Position Summary 100% based on-site in Greendale, IN Work Schedule: Regular business hours, Monday to Friday Greendale is one of Catalent’s gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers. The Compliance Specialist is responsible for supporting and maintaining site quality and regulatory compliance activities at the Greendale facility. This role ensures the integrity of quality systems, supports regulatory, certification, and customer audits, supports supplier quality processes, and drives continuous improvement in compliance and documentation.

Requirements

• Bachelor’s degree in a scientific, engineering, or technical discipline (or equivalent experience) required.
• 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

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.

Benefits

• Several Employee Resource Groups focusing on D&I
• Potential for career growth within an expanding team
• Diverse, inclusive culture
• 152 hours of PTO + 8 Paid Holidays
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
• Join us in making a difference.
• personal initiative.
• dynamic pace.
• meaningful work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level