Specialist II, Product Quality Assurance

• Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
• Provide Quality oversight of QC testing
• Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
• Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
• Real time review of batch records and labels
• Review and approval of manufacturing discrepancies and associated CAPA’s
• Communicating lot disposition pending issues to management
• Aid in the development and ongoing improvement of applicable quality systems for the site
• identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
• Review and approve calibration and maintenance work orders and asset inductions
• Support approval of protocols when required
• Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues
• Responsible for supporting functional and facility goals and objectives
• Responsible for supporting and contributing to quality metrics for the facility
• Responsible for supporting and participating in regulatory inspections
• Responsible for communication and escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or company impact to senior management

• Bachelors or Advanced degree in a scientific discipline
• 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
• Knowledge of aseptic processing, and/or cell and gene therapy is preferred
• Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
• Knowledge of global regulations and standards
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually as well as within a multi-disciplinary team
• Excellent listening, communication and interpersonal skills with a team focus
• Consistent delivery of high-quality work
• Ability to gown and work in a cleanroom environment
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed
• Ability to support 2nd shift schedule

Knowledge of aseptic processing, and/or cell and gene therapy