Posted to MedZilla on 2/16/2020

Takeda Pharmaceuticals

US-CA, Sr Quality Associate B8 SR0046380-MZ


Shift 2 (Swing): This position reports to Swing (2) shift. This shift schedule is Monday-Friday from 2:00 PM to 10:00 PM. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

Summary: Successfully perform all the primary activities as defined in the QA I and QA II job positions.Handle multiple projects.Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem-solving, and team leadership.Lead PMT, QWT, Kaizen or equivalent focus type group activities as required. Utilize standard engineering principles to implement quality engineering solutions in EBM, Delta V and other electronic systems, evaluation, selection and adaptation of various engineering techniques, constructing detailed, accurate project schedules, interfacing with development groups and technical support groups. Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Support in implementation of standard engineering assignments which are typically a significant portion of cGMP, Quality and Compliance. Select cGMP, Quality and Compliance sound techniques to solve problems and CAPAs. Design, lead and perform experiments using sound scientific principles.Provide ownership and oversight of the user Intervention system.A functional understanding of FDA CFR; EMA - EUDRALEX, ISO, and Takeda Quality Systems is also required. Additionally, oversee and support Building 8 Ramp Up activities.

Essential Duties and Responsibilities:

  • Manage ongoing daily departmental activities for areas of direct responsibility. Partner with manufacturing to ensure sound quality decisions are made
  • Manage activities of self and indirect reports in achieving defined quality goals in an efficient, accurate and timely manner
  • Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizen, 5S or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development, and presentation
  • Lead in-plant audit-ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO, and Takeda quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements
  • Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
  • Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant
  • Must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability
  • Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis
  • Assists, writes and/ or reviews validations for equipment, product changes, and computer systems
  • Assists with vendor audits/assessments and provides ongoing feedback related to quality issues
  • Assist in investigations, problems solving sessions and process troubleshooting as assigned
  • Responsible for Risk Assessment, Investigation Review/ Approval and Product Disposition in Exception Management System (GEMS) for assigned CAPA
  • Must be willing to work flex hours and rotations, if necessary


  • Understand scientific strategies and be able to invent new methods or new avenues of investigation
  • Good interpersonal/communication/influencing/negation skills
  • Proficient in writing and reviewing technical documents
  • Good project management skills
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices

Education and/or experience:

  • Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering is ideal
  • Lead Auditor training, ISO Lead Assessor training, with 2-3 years of experience in auditing techniques, interpreting regulations or quality systems
  • Minimum of 5 years of experience in Quality, or related field

Physical Demands:

  • Must be able to lift, push, pull and carry up to 10 lbs
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility

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
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends
  • May be required to work in a confined area
  • Some Clean Room and cool/hot storage conditions
  • 5% travel

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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Pay Transparency Policy -

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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