Specialist I, Quality Assurance

Catalent Pharma Solutions•Kansas City, MO

5d•Onsite

About The Position

We have an opportunity for a Quality Specialist I to join our team supporting clinical trial projects. In this role, you will help ensure compliance with regulatory requirements, good manufacturing practices and standard operating procedures. You will maintain accurate documentation and support quality assurance processes throughout the product lifecycle. This position offers the chance to contribute to continuous improvement initiatives and develop your expertise in a dynamic environment.

Requirements

Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment.
20/30 corrected vision exam with colorblindness testing.
Nurse assessment and pulmonary physical.
Respirator fit test.
DEA background check relating to controlled substance products.
Ability to work in refrigerator (35°F – 46°F / 2°C – 8°C) and/or freezer (-4°F / -20°C) environments.
Ability to work near machinery and packaging equipment.

Nice To Haves

Ability to identify aberrant data and potential quality or compliance concerns and escalate to management.
Ability to work effectively under pressure to meet deadlines.

Responsibilities

Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
Create Certificate of Analysis with supervision. Adhere to GMP standards with guidance and create limited errors
Support clinical trial projects ensuring compliance with regulatory requirements, good manufacturing practices and standard operating procedures.
Implement and maintain quality assurance processes throughout the product lifecycle.
Ensure all documentation is accurate, up-to-date and properly maintained in accordance with regulatory requirements.
All Other Duties as Assigned.