Roger Perkowski Email & Phone Number

•Accurately formulate buffers utilized in the manufacturing process following approved Standard Operating Procedures.•Operate filter integrity tester, pH meter, conductivity meter, scales and balances, pumps, welders, and sealers. •Ensures that processing equipments and analytical instrumentations are qualified, calibrated and maintained as per schedule.•Write SOP’s, batch records, NCR’s, CAPA’s, and validation protocol.•Provide initial review of batch documentation for completeness and accuracy.•Write and revise work schedule as needed.• Maintain trending of production data.•Created an inventory database to monitor and maintain WFI availability for technical operations groups.•Maintain laboratory inventory of materials required for Buffer compounding.•Contributor in the development of a dispensary style of solution preparation from conception to execution. •Operate automated filling equipment to perform liquid fills of sterile products in a Class 100 filling environment.•Inspection of final product vials.•Labeling of final product vials.

•Oversee and coordinate the daily flow of production.•Manage 6-8 operators on a day-to-day basis•Communicate status of operations in a timely manner to management, along with safety and maintenance problems.•Trains junior operators in standard operating procedures.•Contribute and adhere to safety, environmental, quality and EEO/AA standards of the corporation.•Utilize CIP skids to clean manufacturing process equipment.

Production Leader/In-Process Control:•Management of 8-12 operators. •Quality, preparation and submission of FDA required reports for various pharmaceutical products. •In process testing of all products to ensure their quality. •Revise SOP’s to make process more accurate and efficient. Mass Prep:•Operate pressure reaction vessels, pumps, mixers, scales. •Monitor and record process conditions, including temperatures, pressures, vacuum, and material flow. •Monitor process stability to maintain high standards of quality. Class Two Narcotics - Controlled substance experience. Knowledge of GMP’s and SOP’s.