Associate I - Quality Assurance, On the Floor

Catalent Pharma Solutions; Madison (AL); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

PTO 152 hours + 8 holidays

Generous 401K match

Medical, dental and vision benefits on

Tuition Reimbursement

Job summary

Catalent Pharma Solutions is hiring an Associate I - Quality Assurance On The Floor in Madison, WI. This on-site role supports QA on the floor programs, manufacturing walkthroughs, and documentation control to ensure FDA/regulatory compliance and product quality.

The team focuses on ensuring high-quality drug products for clients and patients. The candidate must have STEM education with 0+ years (Bachelor’s), 1+ year (Associate’s), or 4+ years (High School).

Qualifications

• Bachelor’s in STEM with 0+ years of experience.
• Associate’s in STEM with 1+ year.
• High School diploma with 4+ years.

Responsibilities

• Execute QA on the Floor program.
• Conduct manufacturing walkthroughs.
• Provide quality support to operations.
• Release 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

Operations support

Education

Bachelor’s (STEM)

Associate’s (STEM)

High School diploma

Job description

Associate I - Quality Assurance, On The Floor

Position Summary:

• Work Schedule: Sun - Wed AM (6AM - 4PM)
• 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 issuesMaintain 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.

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]. 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.