US-IL, Quality Technician SR0046739-MZ
Responsible for the inspection activities of chemicals and components in the manufacturing process; from quarantine to the release and/or destruction of materials. Identify defects in raw material through the inspection process. Required to sample chemicals in a classified room using appropriate gowning and safety measures. Regularly take inventory of material in non-conforming areas.Must adhere to current Good Manufacturing Practices at all times.
This is a Night shift position 6pm - 6:30am
1)Responsible for: Inspection and release of production materials, components, and chemicals to manufacturing facility; including Intermediate Paste shipment verification.
2)Responsible for sampling Raw Materials in an ISO Classified environment; including preparation and shipment of samples to the required laboratories.
3)Responsible for performing room cleaning and environmental monitoring in the ISO classified Chemical Sampling Rooms.
4)Responsible for CAPA investigations in the event of a failure pertaining to QMRI processes or Raw Material that is deemed to be out of specification.
5)Responsible for document revisions to procedures, forms, and specifications as needed.
6)Perform Returned Goods, Product Holds, and Tagging and Untagging of non-conforming material in a timely manner.
7)Responsible for communicating with third party bonded destroyers for the destruction of Non-Conforming and rejected material.
8)Responsible for appropriate storage and disposal of retention and reserve samples.
9)Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
10)Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines
11)Operate and proactively maintain laboratory and warehouse equipment. Ensure that equipment maintenance is properly documented in a timely manner.
12)Support execution of validations for lab equipment, lab methods, or facility projects
13)Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations
14)Monitor product quality through the performance of required visual and functional testing.
15)Ensure the accuracy of measuring and testing equipment through the performance of calibrations.
16)Promote continuous improvement through participation (i.e. team leader/facilitator or major contributor) in Quality Improvement program.
17)May provide guidance and training to others.
Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
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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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
Please visit our website at takedajobs.com