Posted to MedZilla on 3/18/2019


Takeda Pharmaceuticals

US-MA, Lead Investigator SR0032715-MZ


 
 

Primary Duties

Under general supervision the Lead Investigator will lead evaluation and close out of deviations within the established timelines. Will also evaluate and close out Environmental Monitoring excursions and Metrology Out of Tolerance assessments as required.Conducts investigations of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors to determine product impact, identify root cause, and identify corrective and preventative actions.

Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships throughout the organization.

Responsibilities

  • 70% - Investigate and document findings and impact assessment for deviations mostly minor, some major
  • 10%- Author calibration Out of Tolerance (OOT) impact assessments
  • 10% - Author Environmental Monitoring (EM) excursions impact assessments
  • 5% - Provide subject matter expertise on manufacturing process to support deviations owned by other departments
  • 5%- Participate in continuous improvement initiatives

Education and Experience Requirements

  • Bachelor s in Science, Engineering or a related discipline
  • 2-5 years related experience in the manufacturing and/or development of biologics or 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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.