Principal QA Representative - Medical Device

Company: Catalent
Location: Bloomington
Posted on: March 18, 2023

Job Description:

Principal Quality Assurance Representative - Medical Device

Catalent 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.

The Principal QA Representative - Medical Device is directly responsible for providing support to the Quality function by overseeing GMP activities, documentation and reports that support Medical Device business.

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.

This is a full time, site-based, and salaried role. The schedule is Monday through Friday, 1st shift.

The Role

• Provide QA oversight/approval for med device program
  
• Ensure we have the correct Quality systems & oversight in place to support Medical Device Business
  
• Provide QA Approval as needed to support production of Medical Deviance products
  
• Provide guidance on the concept, design, build, start-up, maintenance, and retire process for Medical Device products
  
• Work on special projects to support the business.
  
• Maintain Quality Systems, Processes and facilities
  
• Provide direction for and reviewing and approving deviations, corrective and preventive actions, vendor assessment, risk assessments and nonconforming material reports
  
• Owns and maintain Quality Key Performance Indicators (KPIs) for area of expertise
  
• All other duties as assigned
  
  
  The Candidate
  
  • Bachelor's degree or higher preferred
    
  • 8+ years of experience with Bachelor's degree
    
  • 12+ years of experience or demonstrated excellence in role with justification
    
  • Minimum 8 years GMP experience in Medical Device Manufacturing
    
  • Minimum 4 years experience in the Quality Function
    
  • Must be able to read and understand English-written job instructions and safety requirements.
    
    
    Why you should join Catalent
    
    • Defined career path and annual performance review and feedback process
      
    • Diverse, inclusive culture
      
    • 152 hours of paid time off annually + 8 paid holidays
      
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
      
    • Competitive salary with quarterly 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 Reimbursement
      
      
      Catalent 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.
      
      Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
      
      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 DisabilityAccommodations@catalent.com . 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 HERE .

Keywords: Catalent, Bloomington , Principal QA Representative - Medical Device, Healthcare , Bloomington, Indiana