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Job Description
Summary:
The Production Associate (PA) 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, responsible for the hands-on execution of all activities in the production area
Essential Duties and Responsibilities:
Supports all local manufacturing operations
Inspects manufactured product for irregularities or defects
Supplies components, small parts, glassware, tubing, etc. to cell culture and purification areas
Operates general production equipment (such as labelers, parts washers, autoclave, stir plates, etc.)
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
Embody the Takeda Leadership Behaviors:
May perform other duties as assigned
Qualifications:
Must be willing and able to work 12 hour shifts – 5am – 5:30pm OR 5:00pm – 5:30am. 2-2-3- configuration.
Must be able to speak, read, write and follow detailed written and oral instructions in the English language
Must have basic written and oral communication skills and ability to learn and comply with current Good Manufacturing Processes (cGMP) regulations
Must have 20/20 vision or better within arm’s length
Must NOT be colorblind
Familiarity with pharmaceutical production equipment preferred, including autoclave, DP oven and CIP/SIP
Good interpersonal skills and ability to work effectively and efficiently in a team environment
This position requires shift, weekend and holiday work; overtime will be required at times (typically 2 Saturdays each month)
The incumbent may work in a clean room environment, requiring 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 immunizations before performing work within the manufacturing area
Education and/or Experience:
Requires AS/AA degree or High School diploma with 0-2 years related manufacturing experience
Physical Demands:
Must be able to lift, push, pull and/or carry up to 30 lbs.
Repetitive motions with hands, wrists, turning head, bending at knees and waist
Walking within and between quality rooms and packaging rooms, as well as throughout the entire plant
Working Environment:
Must be able to work in controlled environments requiring special gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment
May work in a cold, wet environment
Must be able to work multiple shifts, including weekends
Must be able to work overtime as required, including Saturdays
May be required to work in a confined area
May be exposed to some Clean Room and cool/hot storage conditions
May require immunization before performing work within the manufacturing area