Supervisor, Quality Assurance

Catalent•Kansas City, MO

10d•Onsite

About The Position

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Quality Assurance Supervisor will manage the day-to-day activities and employees within their Quality Group. This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). This individual will constantly evaluate the internal processes and procedures and work to create an efficient quality area while maintaining the highest possible quality standards. The Supervisor follows established protocols and work plans. Comply with divisional and site Environmental Health and Safety requirements.

Requirements

Minimum 3 years of experience in a Quality Assurance role in a GxP facility
Strong knowledge of cGMPs and ability to ensure compliance with SOPs and regulatory requirements
Experience supporting QA activities on a manufacturing/packaging floor (e.g., audits, line clearance, in-process checks)
Experience leading or supporting deviations, investigations, and root cause analysis (e.g., fishbone, five whys)
Ability to work cross-functionally and resolve issues with internal stakeholders
Strong communication skills with internal and external customers
Ability to manage multiple priorities and work effectively under pressure to meet deadlines
Strong organizational skills and ability to handle multiple activities simultaneously

Responsibilities

Oversee daily workflow of QA activities on the packaging and distribution floor, including but not limited to: in-process audits, line clearance, cleaning verification, and labeling approval
Train and mentor associates as needed
Resolve problems/issues with internal clients
Identify continuous improvement opportunities within QA
Independently lead improvement and/or other projects within QA
Independently author SOPs and forms
Effectively utilize problem solving tools (i.e., fishbone, five whys) to lead investigations
Communicate effectively with both internal and external customers, peers and management to facilitate the smooth and timely completion of projects
Conduct packaging audits (on-the-floor)
Identify and report cGMP or SOP compliance issues as necessary