Quality Specialist I

About SiteCatalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.Position SummaryWe have an opportunity for a Quality Specialist I to join our team supporting clinical trial projects. In this role, you will help ensure all work complies with regulatory requirements, good manufacturing practices and standard operating procedures. You will be responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This includes ensuring documentation is accurate, current, and properly maintained in line with regulations.Shift: M-F 10am-6pmLocation: Kansas City, MO100% OnsiteThe RoleDemonstrate proven competence and ability to flex to the next level for growth opportunitiesParticipate in continuous improvement initiatives to enhance processes, systems, and procedures related to quality managementInspect components and materials, perform cleaning procedures for sampling, and complete all associated paperworkCreate Certificates of Analysis with supervision and adhere to GMP standards with guidanceReview quality control data for completeness and acceptability, approve release packets, and perform material release with supervisionFile batch record documentation, review documents, and perform redactions with supervisionSupport floor quality assurance activities including in-process audits, cleaning, line clearance, and inspections under supervisionPerform label inspections and releases, and line clearance activities with supervisionReview and approve quality actions and effectiveness checks, lead investigations for deviations and complaints, and host CAPA review meetingsTrack and trend metrics, perform effective rapid response, and maintain DME trainingHost change control review board meetings, review and approve change controls, engineering studies, and periodic reviews with supervisionThe CandidateMinimum RequirementsHigh school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environmentAbility to follow instructions and guidance from othersUse existing procedures to solve routine problemsProactive in addressing work issues at the individual levelAbility to follow written, oral, diagram, or schedule instructionsMathematical and scientific reasoning abilityAbility to identify aberrant data and escalate quality or compliance concernsAbility to work effectively under pressure to meet deadlinesProficient in using computers and related technology for common tasks20/30 corrected vision exam with colorblindness testingNurse assessment and pulmonary physicalRespirator fit testDEA background check for controlled substance productsAbility to work in refrigerated (35F – 46F / 2C – 8C) and freezer (-4F / -20C) environmentsAbility to work near machinery and packaging equipmentPreferred Skills & BackgroundBachelor’s degree in a scientific discipline or equivalent knowledge and experienceWhy You Should Join CatalentDefined career path with annual performance reviews and feedbackDiverse and inclusive culturePotential for career growth within an organization dedicated to improving livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day oneTuition reimbursementCatalent 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 View email address on click.appcast.io. 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 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.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.SummaryLocation: Kansas City, MOType: Full time