Production Associate at Baxalta U.S., Inc. in Round Lake, Illinois

Posted in General Business 9 days ago.

Type: Full-Time





Job Description:

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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

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time