Specialist III - Quality Assurance

Disability Solutions - Madison, WI

Full-time - Mid Level

Madison, WI

501-1,000 employees

About the position

The Specialist III, Quality & Compliance role at Catalent Biologics is focused on ensuring compliance with FDA and other regulatory agency requirements, as well as internal quality systems. This position involves executing internal and customer audits, maintaining facility licenses, organizing documentation for regulatory submissions, and supporting the quality system's effectiveness. The role is essential in safeguarding systems and processes to provide high-quality drug products for clients and their patients.

Responsibilities

• Execute internal audits and coordinate with relevant department subject matter experts.
• Facilitate customer audits and provide accurate information regarding quality systems and operations.
• Maintain facility licenses and registrations.
• Organize documentation for client regulatory submissions.
• Monitor and assess changes to regulatory guidance and compendial monographs.
• Support and enhance the effectiveness of the quality system, including reporting metrics and authoring SOPs.
• Drive alignment and improvement initiatives, leading cross-functional teams.
• Oversee customer Quality Agreements and coordinate their revision and review.
• Draft and execute technical plans, protocols, control strategies, and reports related to process validation.
• Maintain statistical tools for system and process monitoring.

Requirements

• Doctorate Degree in STEM discipline with minimum of 6 years related experience OR Master's Degree in STEM discipline with minimum of 8 years related experience OR Bachelor's Degree in STEM discipline with minimum of 10 years related experience OR Associate's Degree in STEM discipline with minimum of 14 years related experience.
• Ability to communicate effectively in clear English and use Excel, Word, and other office systems.
• Maintain data integrity and ensure compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Ability to independently lead investigations, deviations, and change controls.

Nice-to-haves

• Experience in a clean room environment.
• Familiarity with statistical tools for process monitoring.

Benefits

• Defined career path and annual performance review.
• Diverse, inclusive culture.
• 152 hours of paid time off annually + 8 paid holidays.
• Competitive salary with yearly bonus potential.
• Community engagement and green initiatives.
• Generous 401K match.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement.