Specialist I - Quality Assurance Operations, Client Quality

Specialist I, Quality Assurance, Client Quality

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-the-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.

The Role:

• Responsible for representing 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.

• Accountable for review of Master Batch Production Records and material specifications for prepared solutions and columns.

• Responsible for oversight of the control and management of Cell Bank inventory.

• Provides review and approval of protocols and associated executed reports supporting Manufacturing operations, including media process simulations.

• Responsible for review and approval deviation investigation records.

• Provides training to Quality Assurance and Manufacturing personnel on Quality topics.

• Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems

• Supports direct quality assurance oversight of routine manufacturing operations, including QA on the Floor, issuance of controlled documents, review of executed CGMP documentation, and disposition of prepared solutions and columns.

• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

• Other duties as assigned.

The Candidate:

• 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.

• Ability to use Excel, Word, and other office systems.

• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.

• 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.

Why you should join Catalent:

• 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 - Let us help you finish your degree or start a new degree!