Senior Associate I - Quality Assurance

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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.

The QA Operations Associate assures that all operations at Catalent meet or exceed cGMP regulations and client customer requirements. The QA Operations Associate 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.

This is a full-time on-site salaried 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:

• 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

• Compiles complete batch records through collection of documentation from multiple sources (production, labs, etc.)

• Identifies and drives resolution of all documentation and batch record issues to allow for timely release

• 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:

• Requires Master’s degree in STEM discipline with minimum of 0 years related experience OR

• Bachelor's Degree in STEM discipline with minimum of 3 years related experience OR

• Associate’s Degree in STEM discipline with minimum of 6 years related experience OR

• High School Diploma with a minimum of 7 years related experience

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 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) .