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R&D Production Operator- Lowell, MA
The R&D Production Operator will be a highly skilled production operator. Job duties will include
ensuring that we meet the demand for assembly of testing prototypes, while maintaining process
controls and quality levels. This position will require excellent organization and documentation
skills, adherence to written procedures, ability to operate assembly equipment and perform all
duties that are required within the cleanroom and lab areas. Must comfortable working
independently and in a dynamic, team-based environment to reach common objectives with
aggressive schedules.
Duties and Responsibilities:
• Works in a safe manner and follows safety rules at all times.
• Adheres to all processes, guidelines, and requirements for work areas, such as cleanroom,
microbiology lab, engineering lab, etc.
• Ability to problem solve and communicate issues/resolutions to project management.
• Understands undertakes and implements quality control/assurance techniques and procedures.
• Ability to work with minimal supervision to support assembly of test material, including
documentation of process, material, equipment, test parameters, etc.
• Works in an organized manner and follows procedures to ensure the production of a quality
product.
• Adhere to assembly schedule and ensure that materials are stocked and ready for the day.
• Inspect and ensure that all equipment is calibrated and in working order; balances/scales,
pipettes, heat sealers, etc.
• Performs aseptic techniques while following the SOPs.
• Documents lot numbers of parts and materials, calibration and serial numbers of all equipment
used as well as any specialized test parameters.
• Completes batch process records and ensure they are correct and complete.
• Perform work that is compliant with cGMP, ISO, QMS and other pertinent regulations and
directives.
• Support immediate supervisor and peers by anticipating problems, providing input on solutions,
reacting productively to change and handling other tasks as assigned.
• All other duties assigned by Supervisor.
Qualifications/Experience:
• HS diploma and 2 years’ experience or Associates degree.
• Excellent documentation and organization skills.
• Ability to adhere to a production schedule
• Requires the ability to multi-task and maintain focus.
• Experience with cleanroom assembly is a plus.
• Experience with aseptic process and laboratory skills is a plus.
• Ability to perform simple maintenance and troubleshoot equipment a plus.
• Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus.