Associate, Quality Assurance

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

Catalent’s Kansas City facility supports Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services. The Associate, Quality Assurance performs varied work requiring evaluation and originality while following established protocols and work plans. This role provides quality oversight of manufacturing processes and ensures compliance with cGMPs, FDA and MHRA guidelines, regulations, and internal SOPs. The Associate contributes to product quality and safety and supports continuous improvement initiatives. This is a 100% onsite position 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 approach to addressing work issues individually and as part of 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 technology and common hardware and software, 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, applicable regulations, and internal SOPs.
Identify manufacturing deviations and provide direction on appropriate corrective actions.
Review and approve batch documentation for adherence to 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.