Specialist - Quality Assurance

Specialist I, Quality Assurance

Position Summary:

Work Schedule:

M‑F 8am-5pm. 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 COVID‑19, 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 an Specialist I, Quality Assurance. 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 Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities.

The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on‑floor support, product disposition, and shipping.

The Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.

• Accountable for the compliance and effectiveness of the Supplier and Material Quality Assurance programs.
• Manages and maintains the quality Approved Supplier List.
• Schedule and conduct audits of suppliers and vendors in accordance with site policies and procedures.
• Evaluate audit results and follow up on any outstanding issues/actions.
• Leverage audits performed by sister Catalent sites.
• Responsible for collaboration with Catalent sister sites and suppliers to draft and maintain Quality Agreements.
• Responsible for collaboration with internal Catalent stakeholders to support the Supplier Quality Assurance team in leading corrective action associated with material and supplier quality issues.
• Provides support for the introduction of materials from new suppliers and material qualification program.
• Develop and conduct training to support consistent and accurate execution of the supplier and material quality controls.
• Files and maintains controlled documents.
• Other duties as assigned.

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
• Master’s Degree in STEM discipline with minimum of 4 years related experience.
• Bachelor’s Degree in STEM discipline with minimum of 6 years related experience.
• Associates Degree in STEM discipline with minimum of 10 years related experience.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with quality management software such as Track Wise or Compliance Wire.
• Ability to independently apply CGMPs to everyday work.
• Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Executes procedures of high complexity with high quality.
• Advanced understanding of pharmaceutical laboratory and/or production operations.

• 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.

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