Posted to MedZilla on 2/22/2019

Takeda Pharmaceuticals

US-IL, Quality Analyst I SR0029143-MZ


Summary: The Quality Analyst is the site administrator of the quality document management system at Takeda's Round Lake, IL manufacturing facility, focusing on revisions, reviews and approvals of local document changes; also is responsible for revisions of courses in the learning management system and provides back-up support as needed; notifies plant personnel of new and revised corporate/product documentation Essential Duties and Responsibilities Provides support/troubleshooting for revisions, reviews, and approvals of local document change requests and creates course revisions in learning management system (SABA) Notifies plant personnel of new and revised corporate/product documentation; reviews and files associated documentation Replenishes issued and effective forms in associated book locations as required Owns standard operating procedures related to document control Communicates proactively with internal and external partners and management Performs data entry in the electronic documentation management system and in the electronic learning management system Maintains files such that documents are readily available and easily retrievable Assists department with monthly/quarterly quality system data review metrics and reporting Cross-trains and learns different positions in QA, such as training, critical systems release, and QA Technician roles, to fill in during vacations, leaves, and all-hands-on-deck situations Supports department responsibilities such as batch folder issuance, tracking number issuance, controlled form and document distribution, documentation review, filing, compliance audits, lean initiatives, computer system maintenance, training, etc. Identifies opportunities for continuous and process improvement/efficiencies; leads projects and implements continuous improvement initiatives Trains and mentors less-experienced quality department employees Collaborates within and outside department on special projects, including moving various programs from paper-based to electronic formats Qualifications Strong computer skills including Microsoft Word and intermediate Excel skills required Exposure to and hands-on experience with a variety of applications is strongly desired Knowledge of documentation systems and familiarity with batch/systems documentation and GDP preferred Must be detail-minded and exact in terms of working with documentation Strong drive to be an independent learner Ability to work with minimal supervision in a dynamic environment while following written procedures Must be organized and able to prioritize tasks Ability to communicate efficiently orally and in writing with all levels of the organization (especially with production supervisors, manufacturing associates and the engineering team) and with external clients Must be flexible, thick skinned and adaptable to shift gears gracefully through changing priorities Ability to think on your feet Resourceful with a good sense of humor Must be willing and able to work overtime as needed Cannot be allergic to Cephalosporin drugs Embody the Takeda Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an Excellent Manager of Self and Others. Education and/or Experience High School diploma or equivalent required AA/AS degree preferred 2-5 years of experience, preferably in an FDA-regulated environment (Pharma or food industries) Physical Demands In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility (light to medium work) Must be able to lift, push, pull and carry up to 30 lbs. Working Environment General office environment. Must be willing to adjust work hours and work overtime based on business needs.

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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