Specialist I, Quality Assurance

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

We have an opportunity for a Specialist I, Quality Assurance to join our team. In this role, you will focus on auditing laboratory data to ensure compliance with procedures and regulations in the pharmaceutical industry. You will review critical documentation and support quality processes to maintain high standards. This position plays a key role in ensuring adherence to Good Manufacturing Practices and regulatory guidelines.

Requirements

Bachelor’s degree in a science-related field and 4+ years of related work experience, or Master’s degree in a science-related field with no experience required
Clear communicator in written and verbal form; seeks answers from standards and regulations and escalates when needed
Demonstrates Catalent Leadership Competencies at the Individual level: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops
Responds to problems and identifies solutions; develops methods to address constraints and waits for approval before implementation
Collaborates effectively with others; handles conflict constructively and communicates necessary information
Builds trust by acting ethically and inclusively; ensures compliance with regulations, policies, and standards; raises questions or concerns when needed

Nice To Haves

Veterinary or Human Pharmaceutical Quality Assurance or Quality Control experience strongly preferred

Responsibilities

Process documents submitted to Quality, including scanning, printing, and filing
Perform laboratory data verification and data audits
Lead laboratory facility audits
Review and approve Certificates of Analysis, Analytical Result Forms, Stability Reports, and Stability Protocols
Follow Good Manufacturing Practices and Good Documentation Practices to ensure compliance with FDA, European, and other applicable guidelines
Perform all other duties as assigned