Production Operator III

Company Name:
Rate : $15.00/hr on W2 (All inclusive)
oHigh School Diploma or equivalent.
oMinimum of 3 to 4 years experience in an FDA regulated cGMP process facility.
oMust be able to read, write, analyze/evaluate charts, follow simple diagrams, and follow testing and inspection procedures.
oMust be able to maintain neat, accurate and complete records and logs and use calibration equipment and machine operations.
oMechanical aptitude is required and used to control machine operations including minor equipment repair, identification of problems, and correcting problems.
oMust be able to focus continuous attention to detail operations requiring some diversification approach to fairly routine processes.
oBasic proficiency with PCs (Personal Computers) and basic use of Windows environment is required.
o Responsible for the staging of formulations, compounding of raw materials within +/- weight tolerances, milling , blending, process control monitoring and documentation of such procedures for manufacturing dehydrated culture media (DCM) and liquid media in accordance with production schedules following the appropriate cGMP and department procedures
o Responsible for managing work requirements in a self directed workplace to meet daily and weekly goals.
o Completes all required documentation neatly, accurately, and in accordance with FDA, cGMP and ISO regulations in order to support production requirements.
o Performs cleaning, inspection, verification for calibration and assist in the maintenance of equipment and facility. Maintains related logs and records. Performs equipment troubleshooting.
o Operates and sets up aseptic liquid filling equipment.
o Ability to train and qualify in aseptic gowning techniques, as well as perform all required tasks in an aseptic environment while wearing sterile gowns.
o Maintains liquid filling suite in accordance to established procedures.
o Responsible for maintaining raw material inventory, lab supplies, and equipment that supports production.
o Handles raw materials per cGMP and Safety requirements
o Uses equipment such as pipettors, balances, pH meters, conductivity meters, and HACH readers.
o Promotes a safe work environment. Provides recommendations on maintaining the safety of the work environment. Follows safety procedures. Participates in Environment Health and Safety (EH&S) programs. Initiates a corrective action whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
o May be required to work overtime, and will be responsible for own work and accountable for decisions of moderate score, following through on assigned responsibilities and able to function under minimal supervision and be able to enter data as required into QDMS and other related business systems.
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