Associate Quality Assurance

Associate Quality Assurance

Position Summary

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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

Catalents Kansas City facility is home to our Oral & Specialty Drug Delivery Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms from formulation development and analytical testing to clinical and commercialscale manufacture. The Kansas City facility is a CenterofExcellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for standalone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City MO is hiring an Associate Quality Assurance. The Associate Quality Assurance under general supervision performs work that is varied and that may be somewhat difficult in character but usually involves limited responsibility. Some evaluation originality or ingenuity is required. Follows established protocols and work plans. Comply with divisional and site Environmental Health and Safety requirements.

This is a fulltime onsite hourly position: MondayFriday 1:30pm 12am 2nd Shift.

Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.

The Role

• Responsible for oversight of the Quality support functions associated with the manufacturing of products

• Ensures with a clear understanding that products are manufactured according to applicable cGMPs FDA guidelines MHRA guidelines regulations GXPs and internal SOPs as necessary to accomplish daily tasks

• Identify deviations during manufacturing and provide direction as to the appropriate course of action

• Review and approve batch documentation to adherence to SOPs and cGMPs

• Participates in QA programs procedures and controls to ensure that products conform to established standards and agency guidelines

• Review cleaning logs. Complete monthly and daily facility audits

• Assist with manufacturing floor activities (equipment/room approval facility compliance)

• All other duties as assigned

The Candidate

• High School Diploma or General Education Diploma with at least three years of experience in Manufacturing/Quality Assurance experience in a GMP manufacturing environment is required

• Possess good communication and problemsolving skills highly desired

• Working knowledge of Microsoft Outlook Word Excel Internet Explorer required

• Individual may be required to sit stand walk regularly and occasionally lift up to 50 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse inclusive culture

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of PTO 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic fastpaced work environment

• Community engagement and green initiatives

• Generous 401K match

• Medical dental and vision benefits effective day one of employment

• Tuition Reimbursement Let us help you finish your degree or start a new degree!

• WellHub program to promote overall physical wellness

• Perkspot offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 lifesaving and lifeenhancing 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 . 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.