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Job Description
The Supply Handler (SH) is responsible for executing all processes in production at Takeda’s manufacturing facility in Round Lake, Illinois, while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply; fully participates in both departmental projects and any quality working teams which may be applicable; under the general direction of the lead technician and the overall direction of the supervisor,is responsible for hands-on execution of all activities in the production area; initiates minor revisions to existing documents; troubleshoots simple existing procedures.
Supports all local manufacturing operations
Supplies components, small parts, glassware, tubing, etc. to cell culture and purification areas
Operates general production equipment (such as parts washers, autoclave, stir plates, etc.)
Assures that Production Associates rotate to different stations every 30 minutes
Coordinates break and lunch schedules for PAs in their inspection or packaging rooms
Completes relevant paperwork following GDP/GMP guidelines
Manually cleans all portable equipment and small parts
Participates on Continuous Improvement Teams
Receives and distributes supplies into the production area as necessary
Performs daily cleaning of the production area to maintain in GMP fashion
Prepares media and buffer solutions
Assembles and operates filtration systems
Reviews and revises pertinent documentation as appropriate
Trains new and existing employees/contractors on procedures for which Supply Handler is qualified as trainer
May perform other duties as assigned
Must be willing and able to work 12 hour shift in a 2-2-3 rotation. Shifts are 5am-5:30pm, 5:00pm – 5:30am.
This position is a Shift 12 hour.
Must have good written and oral communication skills in the English language
Strong understanding of cGMP regulations
Must be able to speak, read, write, understand and follow detailed instructions (written and oral) in the English language
Must have 20/20 vision or better within arm’s length
Must NOT be colorblind
Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement
Familiarity with pharmaceutical production equipment including but not limited to autoclave, DP oven and CIP/SIP
Good interpersonal skills and ability to work effectively and efficiently in a team environment
Must be willing and able to work overtime; position requires shift, weekend and holiday work; mandatory overtime will be required, typically 2 Saturdays per month
Will work in a clean room environment wearing special garments; personal protective equipment must be worn due to safety, cGMP and FDA requirements
Knowledge of basic chemical and biological safety procedures
May require immunization before performing work within the manufacturing area
Requires AA degree with 0-2 years of production experience or high school diploma with 1-3 years of related manufacturing experience