Associate, Quality Assurance

Catalent • Kansas City, MO

12d • Onsite

About The Position

The Associate, Quality Assurance supports quality oversight of manufacturing processes at Catalent’s Kansas City facility. The role involves varied work requiring some evaluation and originality while following established protocols and work plans. The associate helps ensure compliance with cGMPs, FDA and MHRA guidelines, regulations, and internal SOPs, contributing to product quality and safety and continuous improvement initiatives.

The position is 100% onsite in Kansas City, Missouri, with a Monday–Friday shift from 6:00 a.m. to 2:30 p.m.

Requirements

• Bachelor’s degree in a scientific discipline or at least one year of Manufacturing or Quality Assurance experience in a GMP environment.
• Ability to follow instructions, guidance, and direction from others.
• Ability to use existing procedures to solve routine problems.
• Ability to apply quality-system elements to identify, classify, and control the status of finished products.
• Proactive in addressing work issues individually and within a team.
• Ability to follow written, oral, diagram, or schedule instructions.
• Strong mathematical and scientific reasoning skills.
• Ability to identify abnormal data and potential quality or compliance concerns and escalate them to management.
• Excellent written and verbal communication skills with internal and external stakeholders.
• Ability to lead by example in alignment with Catalent’s values and culture.
• Ability to recognize unmet needs within the department and business.
• Ability to collaborate effectively with peers and demonstrate leadership capabilities in a matrix environment.
• Strong time-management and efficiency skills.
• Well organized, with the ability to multitask.
• Ability to work effectively under pressure to meet deadlines.
• Proficiency with computer hardware and software for common tasks, including basic Word, Excel, Outlook, and PowerPoint.

Responsibilities

• Oversee Quality support functions associated with product manufacturing.
• Review batch records, cleaning records, and logbooks.
• Ensure products are manufactured in accordance with cGMPs, FDA and MHRA guidelines, regulations, and internal SOPs.
• Identify manufacturing deviations and provide direction on appropriate corrective actions.
• Review and approve batch documentation for compliance with SOPs and cGMPs.
• Participate in Quality Assurance programs, procedures, and controls to ensure products meet established standards and agency guidelines.
• Complete monthly and daily facility audits.
• Assist with manufacturing floor activities, including equipment and room approval and facility compliance.
• Perform 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.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level