Senior Specialist II - Quality Assurance

Catalent•Madison, WI

1d•Onsite

About The Position

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 a Senior Specialist II - Quality Assurance. 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.

Requirements

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 GMPs to everyday work.
Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP,ICH, FDA, EMA regulations or guidelines.
Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.

Responsibilities

Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of production.
Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations.
Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships.
Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports.
Accountable for review and approval of project related deviation investigation records.
Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
Responsible for final approval and disposition of finished product for shipment to customers.
Maintains a high level of understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
Develops and provides training to support the training program for QA and manufacturing on specific quality functions.
Supports and enhances effectiveness of the quality system, including reporting metrics; developing, authoring and approving Standard Operating Procedures (SOPs); identifying improvement opportunities; implementing change control, risk management, and corrective and preventive action processes.
Drives alignment and improvement initiatives, leading cross functional teams to address process improvement, system improvement, and new regulations / expectations.
Acts as the quality contact and Subject Matter Expert (SME) for Quality Assurance operations and Quality management of client programs.
Provide program specific review of documents supporting process validation and regulatory filings.
Lead continuous improvement projects for the Quality Assurance Operations department.
Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Performs and supports any other tasks necessary to maintain the product quality and site CGMP compliance.
All other duties as assigned