Specialist, Quality Assurance

Company: Disability Solutions
Location: Kansas City
Posted on: April 26, 2025

Job Description:

Quality Assurance SpecialistPosition SummaryCatalent, 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.Catalent's 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 commercial-scale manufacture. - The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.Catalent Pharma Solutions in Kansas City, MO is hiring a Quality Assurance Specialist. The Specialist will perform 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. May be assisted by laboratory technicians / assistants. They will comply with divisional and site Environmental Health and Safety requirements.This is a full-time, on-site salary position: Monday - Friday, 1st shift.Catalent is committed to a Patient First culture through excellence in quality and -compliance, and to the safety of every patient, consumer, and Catalent employee. -The Role

• Performs various audit activities including, but not limited to, audit of laboratory data, stability reports, technical reports, method validations, method transfers, laboratory facilities, etc. to assure compliance with applicable site procedures and regulations
• Perform review, approval and issuance of documents (e.g. Certificates of Analysis and Analytical Results Forms)
• Performs review and approval of analytical methods, specifications and protocols
• Follow GXP (e.g. GMP, GDP, etc.) as necessary to accomplish daily tasks
• Meet deadlines according to agreed timeframes and communicate adjustments as needed
• All other duties as assignedThe Candidate:
  • A High School Diploma or General Education Diploma with at least one year of basic work experience in a professional environment is required
  • Associates Degree or Bachelors Degree is preferred
  • Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
  • Mathematical and scientific reasoning ability
  • Strategy is focused on personal time management and efficiency
  • Well organized with ability to multitask
  • Ability to work effectively under pressure to meet deadline
  • Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 poundsWhy 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 + 8 paid holidays
    • Several Employee Resource Groups focusing on D&I
    • Dynamic, fast-paced work environment
    • Community engagement and green initiatives -
    • Generous 401K match -
    • Company match on donations to organizations
    • 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 categoriesCatalent 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 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Lenexa , Specialist, Quality Assurance, Other , Kansas City, Kansas