Posted to MedZilla on 8/21/2019


Takeda Pharmaceuticals

US-MA, Manufacturing Lead Investigator SR0037364-MZ


 
 

Primary Role:

  • Under general supervision the Lead Investigator will lead mainly Level 1 & 2 deviations and potentially Level 3 deviations.
  • Will manage closure within the established timelines for the manufacturing department.
  • Will conduct investigations of moderate scope and complexity to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines.
  • Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.

Responsibilities and Percent of Time

70%:

Completion of Quality systems:

  • Investigate Manufacturing deviations, mainly Levels 1 & 2
  • Provide subject matter input for QC Out of Specification (OOS) and Out of Tolerance (OOT) events
  • May author impact assessment for calibration Out of Tolerance (OOT) events
  • May author impact assessment for Environmental Monitoring (EM) alert/action limit excursions
  • Escalate conflicts that arise.

10%:

Work cross-functionally to assess and analyze deviations to determine impact and root cause

10%:

Identify and initiate corrective and preventative actions for deviations

10%:

Track and identify Quality System and root cause trends and identify opportunities for operational improvements

Education & Experience Requirements:

  • Bachelor s in Science or a related discipline preferred
  • 2-5 years related experience in the manufacturing and/or development of biologics, pharmaceuticals
  • Previous technical writing experience preferred

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.

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

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.


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.