Quality Assurance Specialist II

Company: Disability Solutions
Location: Kansas City
Posted on: February 2, 2025

Job Description:

Quality Assurance Specialist IIPosition SummaryCatalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.----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 II. The QA Specialist II will audit laboratory data for adherence to procedures and regulations related to Pharmaceuticals.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

• Process documents submitted to Quality Assurance, including scanning, printing, filing, etc
• Performs laboratory data audits and data verification, including method validation and method transfer audits
• Lead Laboratory facility audits
• Review and approval of: Certificates of Analysis (CofA), Analytical Result Forms (ARF), Stability Report, Stability/Technical protocols, Technical Reports, Analytical Methods, Specifications, and LIMS specification/product approval
• Assists with training of new associates in the team
• Follow GXP (e.g. Good Manufacturing Practices, Good Documentation Practices, etc.) to ensure compliance with applicable FDA, European, etc. guidelines as necessary to accomplish daily tasks
• All other duties as assignedThe Candidate:
  • Bachelor's degree in science related field and at least six years of related work experience, OR Master's degree in science related field and at least two years of related work experience required
  • Veterinary or Human Pharmaceuticals, or Quality Assurance/Quality Control experience strongly preferred
  • Exhibits all Catalent Leadership Competencies at the "Individual" level and some at "Manager/Supervisor" level for: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops
  • Creates relevant options for addressing problems/opportunities identified; Identifies the constraints and risks associated with the options identified; Considers, evaluates and seeks others' opinions for alternative courses of action; Selects an effective option, based on the information available at the time; Acts decisively by committing the option
  • Collaborates effectively with others; deals with conflict in a positive and constructive manner; communicates information to others who need it
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 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, Blue Springs , Quality Assurance Specialist II, Other , Kansas City, Missouri