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 operationsInspects manufactured product for irregularities or defectsSupplies components, small parts, glassware, tubing, etc. to cell culture and purification areasOperates general production equipment (such as labelers, parts washers, autoclave, stir plates, etc.)Completes relevant paperwork following GDP/GMP guidelinesManually cleans all portable equipment and small partsParticipates on Continuous Improvement TeamsReceives and distributes supplies into the production area as necessaryPerforms daily cleaning of the production area to maintain in GMP fashionEmbody the Takeda Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an Excellent Manager of Self and Others.May perform other duties as assigned

Qualifications:

Must be willing and able to work 1st shift: 7:00am-3:30pm, Monday through FridayMust be able to speak, read, write and follow detailed written and oral instructions in the English languageMust have basic written and oral communication skills and ability to learn and comply with current Good Manufacturing Processes (cGMP) regulationsMust have 20/25 vision or better within arm’s lengthMust NOT be colorblindFamiliarity with pharmaceutical production equipment preferred, including autoclave, DP oven and CIP/SIPGood interpersonal skills and ability to work effectively and efficiently in a team environmentThis 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 garmentsPersonal protective equipment must be worn due to safety, cGMP and FDA requirementsKnowledge of basic chemical and biological safety proceduresMay 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 waistWalking 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 bodyNo make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environmentMay work in a cold, wet environmentMust be able to work multiple shifts, including weekendsMust be able to work overtime as required, including SaturdaysMay be required to work in a confined areaMay be exposed to some Clean Room and cool/hot storage conditionsMay require immunization before performing work within the manufacturing area