Senior Specialist I - Quality Assurance

Company: Disability Solutions
Location: Madison
Posted on: September 28, 2024

Job Description:

Senior Specialist I, Quality AssuranceSummary:Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements.-- This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patientsThis is a full-time on-site position, M-F 8am-5pm--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:

• Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of production.
• Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations.
• Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships.
• Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer and process characterization reports.
• Accountable for review and approval of project related deviation investigation records.
• Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
• Responsible for final approval and disposition of finished product for shipment to customers.
• Maintains a high level of understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
• Develops and provides training to support the training program for QA and manufacturing on specific quality functions.
• Drives alignment and improvement initiatives, leading cross functional teams to address process improvement, system improvement, and new regulations / expectations.
• Acts as the quality contact and Subject Matter Expert (SME) for Quality Assurance operations and Quality management of client programs.
• Provide program specific review of documents supporting process validation and regulatory filings.
• Lead continuous improvement projects for the Quality Assurance Operations department.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Performs and supports any other tasks necessary to maintain the product quality and site CGMP compliance.
• Other duties as assigned.The Candidate
  • Doctorate Degree in STEM discipline with minimum of 7 years related experience,OR
    • Master's Degree in STEM discipline with minimum of 10 years related experience,OR
      • Bachelor's Degree in STEM discipline with minimum of 15 years related experience,OR
        • Associates Degree in STEM discipline with minimum of 17 years related experience.--Position Benefits:
          • Defined career path and annual performance review and feedback process--
          • Diverse, inclusive culture--
          • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--
          • 152 hours of paid time off annually +--8--paid holidays--
          • Competitive salary with yearly bonus potential--
          • Community engagement and green initiatives--
          • Generous 401K match and Paid Time Off accrual--
          • Medical, dental and vision benefits effective day one of employment--
          • Tuition 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 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 .

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