-Learn, understand, and comply with all Company and GMP compliance policies/procedures.-Learn and perform area sanitization procedures in a GMP Manufacturing facility (Formulation Rooms,Staging Areas, Raw Material Dispensing Room, and Airlocks).-Learn and become competent in performing filter integrity testing.-Learn and become competent in cleaning miscellaneous pieces of manufacturing equipment andvessels.-Learn and perform raw material weighing (dispensing) and bulk formulation.-Perform system maintenance PM?s / procedures.-Become and maintain qualification for entry into the Aseptic Core in order to perform sterile filtrations,unload the autoclave, and complete Steam-in-Place operations as deemed necessary by areamanagement.-Perform other duties supporting the production schedule as assigned by area supervision.-Execute tasks/operations with minimal supervision.-Provide training/guidance/leadership for Production Technician I and II personnel.-Supervise the activities of other members of the manufacturing team, taking full responsibility forresults.-Coordinate manufacturing activities with other support groups to receive components, batch records,QC results, etc.-Conduct QTS nonconforming product investigations, identify corrective actions, and implementchanges as needed.-Place purchase orders and monitor supplies.-Perform final batch record reviews before QA review.-Attend mandatory annual hazardous waste training meeting(s) and demonstrate competency in thattraining by passing test(s) administered by the company or consultant providing such training.-Performs special projects and other duties as assigned.
4-7 years
-B.S. degree in chemistry/biology/life sciences is a plus.-Extensive knowledge of and experience in bulk formulation along with equipment cleaning, preparation, and assembly are preferred.-Computer skills in Microsoft Office such as Word and Excel are a plus.
-High school diploma or the equivalent. -Minimum of five years of experience using current Good Manufacturing Practices (GMP) in a regulated manufacturing facility pharmaceutical/biotech/diagnostic industry) with Processing experience.-Adequate communication skills to read, comprehend, and discuss detailed GMP documentation (batch record instructions, Standard Operating Procedures, etc.).-Strong attention to detail.-Ability to perform arithmetic functions to accurately perform or check calculations required in manufacturing instructions.-Leadership experience in training/directing others.-Strong mechanical aptitude.-Ability to troubleshoot, identify problems, and propose solutions.-While performing the duties of this job, the employee is regularly required to use their hands and arms. The employee is frequently required to stand. -The employee must regularly lift and /or move up to 10 pounds, and frequently lift and/or move up to 25 pounds.-Isolator experience
Associate
We are here to help you with your questions.