Associate I - Quality Assurance, On the Floor (3rd Shift)

Catalent; Madison (WI); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

PTO 152 hours

8 paid holidays

401K match

Benefits from day one

Tuition reimbursement

Job summary

Catalent Biologics in Madison, WI is hiring an Associate I for Quality Assurance on the Floor. This on-site role operates on a 3rd shift (Wed-Sat, 8PM-6AM) and focuses on executing QA activities, reviewing records, and ensuring compliance with FDA standards to support diverse therapies and products.

The role emphasizes manufacturing walkthroughs, release of materials, document control, and collaboration with operations to safeguard product quality.

Qualifications

• Bachelor’s (STEM) degree required or equivalent
• Associate’s (STEM) with 1+ year experience accepted
• High School diploma with 4+ years experience accepted in QA environment

Responsibilities

• Execute QA on the Floor program
• Conduct manufacturing walkthroughs
• Provide quality support to operations
• Issue controlled production documents (e.g., batch records, labels)
• Review batch records, test data, logs
• Release solutions and materials
• Inspect final product containers
• Escalate quality/regulatory issues
• Maintain controlled records
• Other duties as assigned

Skills

QA on the Floor

Manufacturing walkthroughs

Quality support

Documentation control

Batch record review

Release of materials

Final product inspection

Escalation of quality issues

Record maintenance

Education

Bachelor’s (STEM)

Associate’s (STEM)

High School diploma

Job description

Associate I - Quality Assurance, On The Floor

Position Summary

• Work Schedule: Wed - Sat 8PM - 6AM (3rd Shift)
• 100% on-site

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

Catalent Pharma Solutions in Madison, WI is hiring a Associate I - Quality Assurance On The Floor.

The Quality Assurance department is responsible for all aspects of the quality assurance 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. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Role

• Execute QA on the Floor program
• Conduct manufacturing walkthroughs
• Provide quality support to operations
• Issue controlled production documents (e.g., batch records, labels)
• Review batch records, test data, logs
• Release solutions and materials
• Inspect final product containers
• Escalate quality/regulatory issues
• Maintain controlled records.
• Other duties as assigned.

The Candidate

• Bachelor’s (STEM): 0+ years experience
• OR Associate’s (STEM): 1+ year
• OR High School diploma: 4+ years

Why you should join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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 to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.