Associate, Quality Assurance

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health benefits on day one

PTO + 8 holidays

Tuition reimbursement

Career growth opportunities

Diversity & inclusion

Job summary

Catalent Kansas City is seeking 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, supporting quality oversight of manufacturing processes, and ensuring compliance with cGMPs, FDA, and MHRA guidelines.

Shift: M-F 6am-2:30pmLocation: Kansas City, MO100% Onsite. The successful candidate will review batch records, identify deviations, approve batch

Qualifications

• Bachelor's degree in a scientific discipline or at least one year GMP experience.
• Follow instructions and apply all elements of the quality system.
• Able to identify issues and communicate with management.
• Strong written and verbal communication with stakeholders.

Responsibilities

• Oversee quality support functions for manufacturing.
• Review batch records, cleaning records, and logbooks.
• Ensure compliance with cGMP, FDA, MHRA and SOPs.
• Identify deviations and direct corrective actions.
• Review and approve batch documentation for SOPs and cGMPs.
• Participate in QA programs, controls and audits.
• Complete monthly and daily facility audits.
• Assist with floor activities and equipment/room approvals.

Skills

Quality oversight

cGMP knowledge

Documentation skills

Data analysis

Communication

Education

Bachelor's degree in a scientific discipline

Tools

MS Office

LIMS

Job description

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

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-2:30pmLocation: Kansas City, MO100% 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 elevate 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).

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

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.