Posted to MedZilla on 8/18/2019

Takeda Pharmaceuticals

US-CA, Quality Assurance Specialist II - Assay Remediation SR0036782-MZ


Plan, develop, lead and evaluate improvement and compliance projects relating to assay method remediation. Responsible for basic project management and documentation authoring (e.g. protocols, reports, regulatory submissions, etc.). Provide technical knowledge and/or support investigation teams in troubleshooting/problem solving activities as applicable. Provide recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works under only very general supervision to meet deadlines/goals.

  • Co-lead ongoing assay remediation daily department activities across all shifts for the Biochemistry Laboratory including supervision of assigned personnel when performing assays and when required assist other Quality areas in the successful performance of these activities.
  • Develop project plans, test procedures and generate protocols, reports and other documentation to support CTP revisions and validation
  • Assist in the development, establishment and monitoring of systems that focus on key indicators of laboratory control; including data mining, statistical analysis, and data interpretation.
  • Be directly involved in and lead multiple process/product improvement projects. These projects may be executed through CAPA, QWT, Kaizen, product quality review or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control.
  • Assist in laboratory audit ready status efforts in understanding FDA, Los Angeles Facility , and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
  • Lead in the development of customer awareness for routine and non-routine test requests,

support activities for Biochemistry, and assist and drive such activities across all shifts.

  • Operational liaison with various customers including Global QC, MI &S Manufacturing, Quality Assurance and Process Development and Technical Services.
  • Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans.
  • Prepare, review and revise, as required, CTPs and SOPs. Write memos, reports, protocols, CPAs and other appropriate documentation as they pertain to Biochemistry operations and procedures.
  • Drive Lean principles such as 5S throughout daily work activities.
  • Assist on assay validation protocols and train analysts on analytical methods

  • Demonstrated track record of managing multiple tasks and projects concurrently and driving projects to completion in a timely manner.
  • Strong organizational skills and ability to plan and suggest resolutions to technical problems.
  • Strong understanding of critical laboratory, manufacturing and facility processes
  • Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.
  • Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office). Capable of performing advanced data analysis through various applications software.
  • Strong interpersonal communication and influencing/negotiation skills. Must have strong verbal and written communication skills.
  • Represent the laboratory through technical presentations, material review board, management reviews, and other department presentations.
  • Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.
  • Must be able to understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
  • General knowledge of statistical techniques. Working knowledge of QSR, CFR, and USP.
  • Proficient with wide variety lab application software.

Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 3+ years of related experience

  • Must be able to lift, push, pull and carry up to 25 lbs.
  • 20/20 near vision required (corrected as acceptable).
  • Must be able to recognize and distinguish among the colors red, yellow, and blue.
  • In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
  • 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. This may include additional hearing protection for loud areas.
  • 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.
  • Will work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
  • Must be able to work supplemental hours as necessary to complete work commitments.
  • Inside working conditions.
  • 5% travel as applicable.

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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