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

Catalent Pharma Solutions; Madison (WI); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

152 hours PTO + 8 holidays

Generous 401K match

Benefits from day one (medical, dental

Vision benefits

Tuition reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI is hiring an Associate I for Quality Assurance On The Floor. This 3rd shift, 100% on-site role supports operations by executing QA on the floor, reviewing batch records and releasing materials, while ensuring compliance with FDA and internal quality systems.

The ideal candidate may have a STEM background with 0+ years (Bachelor’s), 1+ year (Associate), or 4+ years (High School) in related fields, and will participate in continuous improvement and training

Qualifications

• Bachelor’s (STEM) 0+ years experience OR Associate’s (STEM) 1+ year OR High School diploma 4+ years.
• QA on the Floor program experience.
• Manufacturing walkthroughs experience.
• Quality support to operations.
• Review and release of production documents (batch records, labels).
• Inspect final product containers and maintain controlled records.

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.

Education

Bachelor’s STEM

Associate STEM

High School diploma

Job description

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.

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

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.

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 [e-mail].

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.