Associate, Quality Assurance
Catalent Pharma Solutions
Summary
We have an opportunity for an Associate, Quality Assurance to join our team. This role involves performing varied work that requires some evaluation and originality while following established protocols and work plans. The position supports quality oversight of manufacturing processes and ensures compliance with cGMPs, FDA, and MHRA guidelines. The successful candidate will contribute to maintaining high standards of product quality and safety while supporting continuous improvement initiatives.
Job description
Position Summary
We have an opportunity for an Associate, Quality Assurance to join our team. This role involves performing varied work that requires some evaluation and originality while following established protocols and work plans. The position supports quality oversight of manufacturing processes and ensures compliance with cGMPs, FDA, and MHRA guidelines. The successful candidate will contribute to maintaining high standards of product quality and safety while supporting continuous improvement initiatives.
Shift: M-F 6am-2:30pm. Location: Kansas City, MO 100% Onsite.
The Role
- Oversee Quality support functions associated with the manufacturing of products.
- Review batch records, cleaning records, and logbooks.
- Ensure products are manufactured according to applicable current Good Manufacturing Practices (cGMPs), FDA guidelines, MHRA guidelines, regulations, and internal Standard Operating Procedures (SOPs).
- Identify deviations during manufacturing 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.
The Candidate
Minimum Requirements
- Bachelor’s degree in a scientific discipline or at least one year of Manufacturing or Quality Assurance experience in a Good Manufacturing Practice (GMP) environment.
- Ability to follow instructions, guidance, and direction from others.
- Use existing procedures to solve routine problems.
- Apply all elements of the quality system 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 to management.
- Excellent written and verbal communication skills with internal and external stakeholders.
- Lead by example in alignment with Catalent’s values and culture.
- Recognize unmet needs within the department and business.
- 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.
- Work effectively under pressure to meet deadlines.
- Proficient in computer technology, including hardware and software used for common tasks (Word, Excel, Outlook, PowerPoint basics).
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
- Use existing procedures to solve routine problems
- Apply all elements of the quality system 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 to management
- Excellent written and verbal communication skills with internal and external stakeholders
- Lead by example in alignment with Catalent’s values and culture
- Recognize unmet needs within the department and business
- 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
- Work effectively under pressure to meet deadlines
- Proficient in computer technology, including hardware and software used for common tasks (Word, Excel, Outlook, PowerPoint basics)
Benefits
- Paid Time Off
- 8 Paid Holidays
- Medical, Dental & Vision
- Tuition Reimbursement
- Career Growth
- Community Engagement
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.