Onsite QA Specialist I: GMP & Data Audits

Socket.dev; Kansas; On-site; USD 55,000 - 75,000; Full time

Job summary

Catalent is seeking a Specialist I, Quality Assurance at our Kansas City site to audit lab data for GMP compliance and review critical documentation, ensuring adherence to FDA, European, and other guidelines. The role includes processing quality documents, performing data verification and audits, leading facility audits, and reviewing Certificates of Analysis and Stability Protocols, following GMP and GDP practices.

Shift: M-F 8am-5pm; Location: Kansas City, MO; 100% onsite.

Qualifications

• Bachelor’s degree in a science-related field with 4+ years of related work experience, or Master’s degree with no experience required.
• Clear communicator in written and verbal form; seeks answers from standards and regulations.
• Demonstrates Catalent Leadership Competencies at the Individual level.
• Responds to problems and identifies solutions; develops methods to address constraints.
• Collaborates effectively with others; communicates necessary information.
• Ensures compliance with regulations, policies, and standards.

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

Skills

Clear communication

Analytical thinking

Collaboration

Ethical conduct

Quality mindset

Education

Bachelor’s degree in science

Master’s degree in science

Job description

Catalent is seeking a Specialist I, Quality Assurance at our Kansas City site to audit lab data for GMP compliance and review critical documentation, ensuring adherence to FDA, European, and other guidelines. The role includes processing quality documents, performing data verification and audits, leading facility audits, and reviewing Certificates of Analysis and Stability Protocols, following GMP and GDP practices.

Shift: M-F 8am-5pm; Location: Kansas City, MO; 100% onsite.