Specialist - Quality Assurance

Specialist I, Quality Assurance – Catalent Pharma Solutions

Position Summary:

This role ensures compliance with FDA and other regulatory agency requirements for supplier and material quality assurance at Catalent Madison. The specialty focuses on systems implementation, documentation management, training, auditing, material disposition, and overall QA oversight.

• 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 outstanding issues/actions.
• Leverage audits performed by sister Catalent sites.
• Collaborate with sister sites and suppliers to draft and maintain Quality Agreements.
• Collaborate with internal stakeholders to support the Supplier Quality Assurance team in leading corrective action associated with material and supplier quality issues.
• Provide support for the introduction of materials from new suppliers and the material qualification program.
• Develop and conduct training to support consistent and accurate execution of the supplier and material quality controls.
• File and maintain 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.
• Associate's Degree in STEM discipline with minimum of 10 years related experience.
• Proficiency with Excel, Word, and other office systems.
• Prior 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 continual process improvement.
• 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 401(k) match.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement for degree completion or new degree pursuit.

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