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R&D Laboratory/Manufacturing Technician

Company: Yoh Services, LLC
Location: Durham
Posted on: July 24, 2019

Job Description:

The R&D Laboratory/Manufacturing Technician position is responsible for the operation of equipment used in the production of medical devices with aseptic technique preferred. This individual will assist in product development including setting up a pilot manufacturing line. Responsibilities will include setup, part assembly, aseptic filling, and cleaning of equipment. Additionally, this individual will be responsible for completing batch documentation.Accountabilities Participate in new product development and assist with pilot line production runs Execute pilot production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs. Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner. Express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders and specifications. Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product. Assist with manufacturing deviation analysis and other process equipment related quality concerns. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations. Comply with all safety policies and procedures at all times. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties. Proficient in the use of computers and Microsoft Office tools. Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements. Demonstrate and work towards developing the following attributes: Being open to change and new information; adapt behavior or work methods in response to new information, changing conditions, or unexpected obstacles. Show understanding, courtesy, tact, concern, and respect to others; develop and maintain positive working relationships with others; may include effectively dealing with individuals who have different viewpoints; relate well to individuals from varied backgrounds. Perform other duties as assigned by Management. Qualifications & Experience 1-5 years in a regulated production/operations environment, preferably in the pharmaceutical/biotech industry required. Associates Degree in an applicable or Technical field or Vocational / Technical School preferred. Knowledge of aseptic technique and good lab practices preferred. Knowledge of FDA and/or GMP regulations preferred. Ability to rapidly learn new procedures. Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75 day period of working with a trainer. Ability to work in a team environment with minimum supervision. Physical Requirements Performs all job functions and responsibilities in a safe and responsible manner. Ability to regularly climb stairs to perform work. Ability to stand for extended periods of time on shifts that could range from 8-12 hours. Ability to routinely lift 20-40 lbs. Ability to maintain reliable and punctual attendance. May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials. May be exposed to strong odors incurred during operations. Lab work is performed wearing various types of PPE which include but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas of Manufacturing.

Keywords: Yoh Services, LLC, Lynchburg , R&D Laboratory/Manufacturing Technician, Healthcare , Durham, Virginia

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