Specialist III - Quality Assurance

Position Summary

Work Schedule: M-F 8am-5pm
100% on-site

About the role

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.

Responsibilities

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
• Lead continuous improvement projects for the Quality Assurance Operations department.
• Review and approve Master Batch Production Records and material specifications for prepared solutions and columns.
• Oversight of the control and management of Cell Bank inventory.
• Provide review and approval of protocols and associated executed reports supporting Manufacturing operations, including media process simulations.
• Develop and provide training to Quality Assurance and Manufacturing personnel on Quality topics.
• Maintain a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
• Responsible for all other duties as assigned.

Requirements

• Doctorate Degree in STEM discipline with minimum of 6 years related experience.
• ORMaster's Degree in STEM discipline with minimum of 8 years related experience.
• ORBachelor's Degree in STEM discipline with minimum of 10 years related experience.
• ORAssociates Degree in STEM discipline with minimum of 14 years related experience.
• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.

Qualifications

• 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

Benefits

• 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!

Pay

Commensurate with experience

Schedule

M-F 8am-5pm

Benefits

• 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!