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Supervisor - Quality Assurance, QA Operations

3 months ago

Madison, Wisconsin, United States Catalent Pharma Solutions Full time

We're hiring for a Supervisor – Quality Assurance to support the Quality Assurance Operations group at our facility in Madison, Wisconsin

Catalent is a global, high-growth 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 Supervisor – Quality Assurance, QA Operations is responsible for providing leadership oversight, overseeing quality assurance functions, and internal quality systems. This role supports the operations group and is responsible for oversight of manufacturing areas and on-the-floor support. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday, 8:00AM – 5:00PM.

Catalent's Madison, Wisconsin site is a state-of-the-art biomanufacturing facility specializing in integrated formulation and analytical services. Our site features our proprietary Gene Expression Technology (GPEx) cell line engineering platform, and biomanufacturing capabilities utilizing single-use systems. Our employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.

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

  • Accountable for daily operations to maintain Quality standards and project timelines, including execution of work, coordinator with stakeholders and communication with leadership.
  • Responsible for collaboration with internal Catalent stakeholders to review results of quality assessments, maintain effective and efficient processes, and ensure appropriate test directives are established and maintained.
  • Supports execution of the Quality Management Systems in cGMP manufacturing and quality control.
  • Tracks and reports performance indicators.
  • Implement action plans to address gaps and achieve department objectives.
  • Other duties as assigned.

The Candidate

  • Master's, Bachelor's, or Associate's degree in a STEM discipline with a minimum of 4 years related experience, or Doctorate degree in a STEM discipline with a minimum of 2 years related experience.
  • GMP experience preferred.
  • Leadership experience preferred.
  • Excellent written and verbal communication skills with internal and external customers.
  • Maintains data integrity and ensure compliance with company SOP's, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines.
  • Strong organization with ability to handle and direct multiple activities within the group simultaneously.

Why you should join Catalent

  • Defined career path and annual performance review and feedback process.
  • Medical, dental and vision benefits are effective on the first day of employment.
  • Potential for career growth on an expanding team and organization.
  • 152 hours of paid time off annually plus 8 paid holidays.
  • Community engagement and green initiatives.
  • Competitive salary with bonus potential.
  • Tuition reimbursement program.
  • Diverse, inclusive culture.
  • Generous 401K match.

​

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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ) .