Compliance Specialist II

Catalent Pharma Solutions • Kansas City, MO

1d • Onsite

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 guidance of a supervisor to ensure all documentation meets regulatory requirements, good manufacturing practices, and standard operating procedures. This position is key to maintaining quality and readiness for client interactions.

Requirements

• High School Diploma or General Educational Development (GED) or equivalent years of experience in a regulated industry.
• Ability to work effectively under pressure and meet deadlines while maintaining attention to detail.
• Ability to 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.

Nice To Haves

• Not applicable.

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

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED