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.• Provide customers with any Analytical updates and requests in a timely fashion.Implementation of all method development, transfers, qualifications, and validations.Writing/ Development/ Review/Assignment of new test method procedures.Review and update existing method procedures and work instructions.Observe and Enforcement of cGMP and safety rules.Testing of incoming chemicals, in process, bulk, expired and finished products.Issuing approval, rejection, hold and transfer tags.Schedule/manage preventative maintenance and qualifications on all laboratory equipment.Review all batch record and raw material routings.Review all COAs sent to customers and ADPRs.Third party review batch records.Review and investigate all OOS findings.Assess critical-to-quality gaps, determine root causes, build business cases for improvement opportunities and implement control procedures to measure and monitor results.Builds relationships with business leaders to understand business objectives and priorities, and to collaboratively identify quality improvement initiatives.Manages and directs testing team direct reports; Provide supervision, coaching and counseling to assigned staff.

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. • Training of analytical chemists to streamline procedures in the pursuit of operational efficiency of the analytical lab unit.• Quality review of Chemical Raw Material Routings, ensuring that chemical test sheets are created to adhere to customer specifications, 21 CFR Parts 210&211 and overall set the quality standard for all incoming raw materials.• Directly involved with the investigation and oversight of quality non-compliance presented in manufacturing and production.• Operate as the analytical liaison for other departments during second shift.• Review and approval of line changeover forms for production during second shift.• Maintain a robust cross-functional relationship with R&D, Engineering, Production, Compounding, Chemical Receiving, Documents, Micro and Analytical Departments.• Created, designed, and implemented a robust certificate of analysis creation process to streamline certificate of analysis generation for all customers.

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.• Provide oversight and approval of cGMP lab and compounding documents.• Collaborate with peers and senior laboratory personnel to create and implement laboratory work instructions• Provide technical assistance to production and compounding on issues related to product quality.