Sr. Associate, Quality Assurance Operations SIGN ON BONUS OFFERED

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Job description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Position Summary:

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 quality assurance and quality control 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 for the facility. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material, Master Cell Bank, and API release.

This is a full-time, hourly position: Monday - Friday, 8:00 am - 5:00 pm

The Quality Assurance Senior Associate -Operations assures that all operations at Catalent meet or exceed cGMP regulations and client customer requirements. The Quality Assurance Senior Associate -Operations assures the quality of Cell Banks and Bulk Drug Substance produced and supports release of BDS for further clinical manufacturing of drug product. This position also ensures quality of manufacturing and laboratory data and reports. This is accomplished by direct collaboration and oversight of Manufacturing Operations and Quality Control and the review/audit of data and reports as specified by Standard Operating Procedures.

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:

• Serves as 'Quality on the floor' to assist and support manufacturing staff in detecting and solving compliance errors in real time.
• Audits GMP areas including during production.
• Reviews batch records, QC testing records, and all supporting records
• Reviews ancillary facility and equipment records in support of GMP operations.
• Reviews assay qualification, equipment, and stability protocols
• Maintains effectiveness of the Quality System.
• Assures the Cell Bank and Bulk Drug Substance are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
• Other duties as assigned.

The Candidate:

• Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; or
• Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 3 years' related experience; or
• Or Associate Degree in technical discipline (biology, biotechnology, engineering) or related life science with minimum of 4 years' related experience.
• Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
• Good working knowledge of quality systems and risk management.
• Communicate effectively and follow detailed written and verbal instructions; ability to clearly communicate with supervisor, group members, and other departments as necessary
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

Catalent 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
• 19 days 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
• 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.
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C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.