Joseph Griego, Cqa Email & Phone Number

Denver, CO, US

Windsor, Colorado, United States

• Responsible for providing scientific support for the QA/QC, regulatory, manufacturing, and development groups. Essential Duties & Responsibilities
• Perform process and formulation optimization for commercial product line to achieve financial goals of product improvement activities.
• Prepare scientific documentation describing and supporting process changes and improvements for regulatory submissions.
• Lead process improvement efforts with designated projects in areas including formulations, optimization and scale-up.
• Serve as a company resource, providing technical direction.
• Make scientific recommendations to management as to the acceptability and quality of affected product lots.

• Maintain the knowledge and the history of the products/process throughout the entire commercial lifecycle, since transfer from development and validation of the commercial process. Establish collaborative relationship.
• Utilize data trending and statistical analysis to deepen and broaden process understanding and knowledge. Detect issues in process capability, such as systematic quality defects. Identify trends of process deviations.
• Change agent (change control) for all aspects that impact raw materials, finished products, the validated process and packaging components. The scope would also include process control improvements through automation.
• Provide technical support in any internal or external FDA audits.
• Accountable for executing updates to batch records and SOPs that impact the product or process.
• Provide technical off hour support 24/7 to manufacturing to remediate issues during processing and/or to immediately triage the process event. Responsible for conducting investigations and CAPA that impact product.

• Develop, implement and maintain pharmaceutical processes to support commercial manufacturing.
• Design, develop and conduct studies to ensure proper sequence of operations and appropriate specifications for robust bio-equivalent formulas and processes. Identify and evaluate critical formulation and processing.
• Perform troubleshooting activities and conduct high profile investigations that interrupt the supply of commercial products.
• Performs atypical and scientifically complicated research, technical assessments and is recognized as a top scientific leader.
• Served as a corporate resource by providing broad technical support for development and commercial products.
• Establishes procedures and specifications; writes and reviews reports and regulatory documents.

• Ensure compliance with safety and cGMP policies and procedures.
• Manage dispensing, granulation, tableting, encapsulation, coating and imprinting operations and staff up to 40 technicians. Experience managing across 1st, 2nd and 3rd shifts.
• Oversee daily productivity, quality and safety requirements.
• Coordinate equipment and process needs with numerous support departments.
• Track departmental performance and oversee team and technician development.
• Maintain the integrity of validated processes and equipment.

• Performed all processing activities associated with the manufacture of bulk pharmaceutical granulations.
• Responsible for cleaning, set-up, and operation of granulation equipment including ancillary equipment.
• Responsible for adherence to standard operation procedures.