Posted to MedZilla on 2/23/2019


Takeda Pharmaceuticals

US-CA, QCA Lead SR0032300-MZ


 
 

Essential Duties & Responsibilities

  • Expected to demonstrate skills and knowledge of Quality Control Analyst II.
  • Use laboratory instrumentation and analytical equipment to test samples. Use computer systems (L(MS) to collect and record data.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Perform review of test data, which includes overall documentation practices (cGDP). Perform release functions in LIMS or other computerized systems.
  • May prepare monthly quality trend reports.
  • Maintain test equipment, equipment maintenance and calibrations as required.
  • Assist or initiate special projects / protocol testing that involves new methods and instrumentation and oversee testing activities.
  • Lead or participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
  • Apply advanced laboratory skills to perform complex assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
  • Investigate complex nonconformances and write exception documents or lead others in writing investigation.
  • Handle multiple tasks concurrently including testing, special project/protocol testing in a timely and appropriate manner.
  • Perform final approval of exception documents, test data, and release functions in LMS or other computerized systems.
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
  • In leadership focused roles, mentor other QCA II or QCA I positions. Provide training, explain process and provide work direction for QCA II or QCA I positions on complex processes as required.
  • A technical expert for their specific part of the process.
  • Troubleshoot and resolve process related issues or assay and instrument problems.
  • Write and execute validations for manufacturing processes and laboratory instruments and methods.
  • Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
  • In leadership focused roles, may manage work flow and laboratory release functions in specified laboratory areas and on off shifts.
  • May perform other duties as assigned.

Lead Role:

  • Manage work flow and laboratory release functions in specified laboratory areas and on off shifts.
  • Mentor other QCA positions. Provide training, explain process, and provide work direction for other QCA positions as required.
  • Handle multiple tasks concurrently including scheduling, routine testing, and special project/protocol testing in a timely and appropriate manner.
  • Investigate complex nonconformances and write exception documents or lead others in writing investigation.
  • Troubleshoot and resolve process related issues or assay and instrument problems.
  • Lead functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
  • Lead functions to support project-specific work (for example, shutdown/startup and execution of validation-related protocols)
  • Representing the Quality Labs in cross functional meetings
  • Lead activities associated with data trending (Quality Control Microbiology)

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.