Catalent Pharma Solutions

Specialist I – Quality Assurance, Client Quality

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.

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 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 Specialist is responsible for the quality assurance functions at Catalent, Madison. The position primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements by developing and implementing quality assurance policies. This includes Identifying production, process, or product issues, documentation management, internal and external auditing, interfacing with clients and managing client quality relationship. Quality Assurance Specialist involves serving as the main point of contact for designated projects, collaborating both internally and externally across different functions. This includes aiding in the integration of the client's program into Catalent quality management system and ensuring successful management of client expectations.

This is a full-time on-site position, Monday - Friday, 8:00am to 5:00pm CST.

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 sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems

• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

• All other duties as assigned

The Candidate:

• Requires Doctorate Degree in STEM discipline with minimum of 0 years related experience OR

• Master’s degree in STEM discipline with minimum of 4 years related experience OR

• Bachelor's Degree in STEM discipline with minimum of 6 years related experience OR

• Associates Degree in STEM discipline with minimum of 10 years related experience.

• Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.

• Ability to use Excel, Word, and other office systems.

• Detail-oriented and well-organized with the ability to work effectively under high pressure with multiple deadlines.

• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

Why you should join Catalent:

• 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 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .