Compliance Specialist II
About The Position
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. We have an opportunity for a Compliance Specialist II to join our team. In this role, you will support cGMP business units to ensure a high level of compliance. You will work under the direct guidance of a supervisor to ensure all documentation meets regulatory requirements, good manufacturing practices (cGMP), and standard operating procedures (SOPs). This position is key to maintaining quality and compliance across our operations.
Requirements
- High School Diploma
- Ability to lift up to 50 pounds
Nice To Haves
- GMP experience is preferred
Responsibilities
- Review executed batch records and documentation to ensure conformance to cGMPs, SOPs, and other protocols.
- Draft and review batch records for use by pharmaceutics and operations personnel.
- Recommend batch record changes for continuous improvement per approved SOPs and collaborate with cGMP business units to resolve inconsistencies.
- Draft standard operating procedures for processes used by pharmaceutics and operations personnel.
- Complete all assigned training and follow training guidelines strictly.
- Maintain high-quality manufacturing documentation in accordance with regulatory guidance and site SOPs.
- Maintain readiness for on-site clients.
- Perform spot-checks of experimental areas and assets, and track laboratory notebooks.
- Track and trend batch record initiation, approvals, updates, and feedback after execution.
- Perform all other duties as assigned.
Benefits
- Competitive paid time off plus 8 paid holidays
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
