Posted to MedZilla on 1/16/2019

Takeda Pharmaceuticals

US-IL, Quality Technician - 3rd Shift SR0027626-MZ


SUMMARY: The Quality Technician (QT) is responsible for performing a wide variety of assignments in the Takeda manufacturing facility in Round Lake. The primary responsibilities of this new position include ensuring compliance with procedures and regulatory requirements and providing Quality support and oversight of daily manufacturing operations. Responsibilities include: label copy control, product nonconformance resolution, sample management, documentation review and approval, and other quality department functions. This is a 3rd shift role; normal working days are: Tuesday nights (11:00pm) into Wednesday mornings (7:30am) through Saturday nights (11:00pm) into Sunday mornings (7:30am). JOB RESPONSIBILITIES: Issue controlled label copy material to manufacturing, ensuring the correct materials are supplied; maintain department equipment and inventory levels for controlled materials Provide Quality support and oversight of daily manufacturing operations; respond to issues which arise on the manufacturing lines and lead corrections to address quality concerns Assist with control of in-process sampling activities and ensure timely delivery of samples to appropriate QC test laboratories; manage finished product file/retain samples Perform material/component release and in-process work order release using JDEdwards C3ME system Perform review and approval of batch documentation and consult with manufacturing to address any required corrections Perform routine audits of the manufacturing areas to assess current safety and compliance risks Make detailed observations, analyze data, and interpret results Interact with manufacturing on a daily basis Perform troubleshooting, work independently, and make decisions based on local procedures and corporate documents QUALIFICATIONS: *** The candidate must not be allergic to cephalosporin drugs *** The candidate must be able to work flexible hours (including hours before or after assigned shift and weekends) in a dynamic environment with minimal direct supervision Applicant cannot be color blind and must be able to pass a vision screening Good written and oral communication skills Problem solving skills are required Ability to work in a team environment and make independent decisions based on procedural and regulatory requirements Knowledge and understanding of cGMPs and GDPs Must be able to work overtime as required May require immunization before performing work within the manufacturing area EDUCATION AND/OR EXPERIENCE: High School Diploma or GED equivalent required Experience with operating of a forklift; certification is a plus Experience with product functional testing is a plus PHYSICAL DEMANDS: Must be able to lift, push, pull and/or carry up to 35 lbs. Sitting, standing, and walking required during every shift Pushing, pulling and stretching may be required occasionally Repetitive motions with hands, wrists, turning head, bending at knees and waist Walking within and between filling, inspection 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 May be required to work in a confined area May be exposed to some Clean Room and cool/hot storage conditions

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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