Compliance Specialist III
Catalent Pharma Solutions
Summary
We have an opportunity for a Compliance Specialist III to join our team. In this role, you will support the preparation, review, and approval of technical and regulatory documentation. You will ensure compliance with current Good Manufacturing Practices and internal procedures. This position offers the chance to contribute to high-quality pharmaceutical operations and continuous improvement within a dynamic environment.
Job description
Position Summary
We have an opportunity for a Compliance Specialist III to join our team. In this role, you will support the preparation, review, and approval of technical and regulatory documentation. You will ensure compliance with current Good Manufacturing Practices and internal procedures. This position offers the chance to contribute to high-quality pharmaceutical operations and continuous improvement within a dynamic environment.
Shift: Monday - Friday, 8am - 5pm. Location: Kansas City, MO. 100% Onsite.
The Role
- Author and approve technical documents such as protocols, reports, and operating procedures.
- Review technical documents for accuracy, thoroughness, and regulatory compliance.
- Review executed batch records and documentation to ensure conformance to appropriate current Good Manufacturing Practices, Standard Operating Procedures, and other protocols.
- Draft and review batch records for use by pharmaceutics and/or operations personnel.
- Draft Standard Operating Procedures for processes used by pharmaceutics and/or operations personnel.
- Perform spot-checks of experimental areas and assets, and track laboratory notebooks.
- Track and trend batch record initiation, approvals, updates, and feedback after execution.
- Maintain readiness for on-site clients.
- All other duties as assigned.
Minimum Requirements
- Bachelor’s Degree; High School Diploma or equivalent years of experience in a regulated industry.
- Ability to work effectively under pressure and meet deadlines while maintaining attention to detail, multitask, and follow a variety of instructions furnished in written, oral, diagram, or schedule form.
- Mathematical and scientific reasoning ability.
- Strong computer skills and proficiency in Microsoft Word and Microsoft Excel.
- Proactive in addressing work issues at the individual level.
Requirements
- Bachelor’s Degree; High School Diploma or equivalent years of experience in a regulated industry.
- Ability to work effectively under pressure and meet deadlines while maintaining attention to detail, multitask, and follow a variety of instructions furnished in written, oral, diagram, or schedule form.
- Mathematical and scientific reasoning ability.
- Strong computer skills and proficiency in Microsoft Word and Microsoft Excel.
- Proactive in addressing work issues at the individual level.
Benefits
- Medical, Dental & Vision
- Paid Time Off
- Paid Holidays
- Tuition Reimbursement
- Career Development
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.