Frank Rister Jr Email & Phone Number

• Ensure compliance with all applicable Customer,FDA, Health Canada and EMA regulations.
• Provide guidance to site on quality compliancestandards and expectations.
• Manage the Batch Release Process: completes qualityassurance operational requirements by scheduling and assigning employees andproviding adequate oversight to ensure that requirements are met.
• Streamline departmental procedures and ensure staffare trained in pursuit of robust compliance and operating efficiency.
• Organize the shifts workload to ensure adequate oversight of cGMP, FDA, customer specifications, processes, and responsibilities.
• Communicate with Upper Management, customers, vendors and staff to ensure alignment on Analytical activities.

Hodgkins, Illinois

• Result driven analytical chemist leading quality laboratory team toward one goal of efficient data centered standard of testing and results.
• Direct team to completion of project plans and modifications as necessary to meet quality goals.
• Organize the shifts workload to ensure adequate oversight of cGMP, FDA, customer specifications, processes, and responsibilities.
• Management of the batch release process for the shift. Schedule and assign responsibilities and accountability to ensure that all cGMP/FDA/Customer requirements are met.
• Interface with the chemical coordinator to assist in the receipt, review and submittal of received raw materials.
• Quality review of Annual Drug Product Review reports to ensure accuracy and alignment with formulation specs and trends.

Hodgkins, Illinois

• Adhere to cGMP, FDA regulations, and customer specifications.
• Assisted in HPLC method development and cleaning validations.
• Testing and release of in-process, finished good materials, and raw materials.
• Maintain an effective teamwork relationship with compounding and production.
• Provide technical assistance to production and compounding departments.
• Creation of OOS lab reports.