Principal Quality Assurance Representative – Data Integrity

Position Summary:

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 is directly responsible for providing support to the Quality function by overseeing GMP activities, documentation and reports.

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.

On -Site, Full Time, Salaried Position

Monday to Friday 1st shift

The Role

• Responsible for Data Integrity Program and Compliance at the Bloomington site

• Leads Data Integrity Projects and Initiatives for the Bloomington site

• Responsible for Data Integrity Assessments

• Review & approve items in our quality systems – CAPA/Deviations/Change control.

• Work on special projects to support the business.

• Maintain Quality Systems, Processes and facilities

• Provide review and approval of documents in the EDMS system

• Provide direction for and reviewing and approving deviations, corrective and preventive actions, vendor assessment, risk assessments and nonconforming material reports

• Maintain Quality Key Performance Indicators (KPIs) for Quality related products

• 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 4 years GxP experience or other regulated industry

• 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

• On-site fitness center and wellness programs

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.