Compliance Specialist

Compliance Specialist

Position Summary

• 100% based on-site in Greendale IN

• Work Schedule: Regular business hours Monday to Friday

Greendale is one of Catalents 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.

The Role

• 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.

The Candidate

• Bachelors 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

Why You Should Join Catalent

• 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 7000 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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