Quality Assurance Specialist

Quality Assurance SpecialistCatalent, 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 Quality Assurance Specialist 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. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.This is a full-time, on-site salary position.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 RolePerforms batch record review, product release, and dispositionDraft, review and approve technical documents such as procedures or master batch recordsEnsures that products are manufactured, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPsParticipates in the development and maintenance of QA programs, procedures and controls to ensure that products conform to established standards and agency guidelinesTrain, coach and mentor others on technical, personal development or business issuesAssists in data compilation of annual product reviewResponsible for QA advisement for project outcome and customer interactionAll other duties as assignedThe Candidate:Master's degree in Scientific discipline with no experience or Bachelor's degree in a Scientific discipline with at least one year experience in Quality Assurance, Quality Control or Regulatory Compliance experience in a GMP environment or Associate's degree with at least three years of experience in FDA regulated field and at least one year of experience in Quality Assurance, Quality Control or Regulatory Compliance or High School diploma with at least five years of experience in FDA regulated field and at least year of experience in Quality Assurance, Quality Control or Regulatory Compliance is requiredSix Sigma or ASQ certification preferredPerforms batch record review, product release, and dispositionDraft, review and approve technical documents such as procedures or master batch recordsParticipates in the development and maintenance of QA programs, procedures and controls to ensure that products conform to established standards and agency guidelinesResponsible for QA advisement for project outcome and customer interactionParticipates in the development and implementation of process related improvementsIndividual 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 processDiverse, inclusive culturePositive working environment focusing on continually improving processes to remain innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives152 Hours + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity engagement and green initiativesGenerous 401K matchCompany match on donations to organizationsMedical, dental and vision benefits effective day one of employmentTuition Reimbursement – Let us help you finish your degree or start a new degree!WellHub program to promote overall physical wellnessPerkspot - 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.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 View email address on click.appcast.io 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 View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.