Specialist I - Quality Assurance Operations, Compliance

Catalent Pharma Solutions • Madison, WI

2d • Onsite

About The Position

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 Specialist I - Quality Assurance Operations, Compliance. 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 actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

Requirements

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
• OR Master's Degree in STEM discipline with minimum of 4 years related experience.
• OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience.
• OR Associates Degree in STEM discipline with minimum of 10 years related experience.

Responsibilities

• Executes internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures; communicating audit findings to key stakeholders; assisting with the review of audit responses.
• Supports customer audits, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions.
• Maintains facility licenses and registrations.
• Organizes documentation and facilitates review in support of client regulatory submissions.
• Monitors and assesses changes to regulatory guidance and compendial monographs.
• Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes.
• Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations.
• Oversees customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements.
• Drafts and executes technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR).
• Maintains statistical tools to meet requirements for system and process monitoring and review.
• Maintains a sufficient understanding of the quality systems and operations to provide oversight and decision making.
• Files and maintains controlled documents.
• Other duties as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree