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Quality Control Analyst - Microbiology

Dunboyne, Ireland


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Quality Control Analyst - Microbiology

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Job ID SR0033552 Date posted 10/10/2019 Location Dunboyne, Ireland

This role will support the Microbiology Laboratory Start-up activities at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland.  The overall responsibility for this role will be to support the Microbiology Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.


  • Conduct microbiology analysis including bioburden testing, endotoxin testing, microbial identification as required.
  • Carry out environmental monitoring including viable and non-viable particulate monitoring and water testing in the manufacturing facility.
  • Participate in the technical transfer/validation /verification of microbiological and analytical testing procedures.
  • Ensure that all cGMP, company specifications, procedures and guidelines are followed.
  • Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
  • Investigate Non -Conformances and actively lead subsequent corrective actions as required.
  • Participate in and responsible for QC related CAPA’s.
  • Adhere to the Quality Control (QC) documentation system and prepare and review document change requests as required.
  • Develop, improve and implement QC procedures, processes and systems.
  • Support projects and continuous improvement initiatives within the Quality department and other functional areas.
  • Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times.
  • Provide hands-on guidance and training when needed.
  • Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
  • Champion site metrics to ensure targets are achieved and countermeasures in place when applicable.
  • Promote and exhibit Takeda Values.
  • Execute company policies.

Education and Experience Requirements

  • A min. of a Level 8 Bachelor’s degree in a technical discipline (e.g. microbiology, biochemistry, chemistry, engineering).
  • Experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company.
  • Experience of microbiology testing
  • Excellent communication skills (written and oral).
  • An understanding of cGMP requirements for manufacturing and/or systems and compliance.
  • Required to work on his/her own initiative in addition to working as part of a team.
  • Excellent time management & organisational skills.
  • Demonstrated understanding of continuous quality/process improvement tools (As defined by the site, e.g. DMIAC, Lean QA, 5S etc).

Key Skills, Abilities, and Competencies

  • Excellent troubleshooting and problem-solving skills.
  • Ability to challenge the status quo with a continuous improvement mindset.
  • Promoting a culture where diversity and inclusion is part of the DNA.

Complexity and Problem Solving

  • Identifying and communicating risks in the area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Contol operation.
  • Identifying and communicating risks in the area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Contol operation.

Internal and External Contacts

  • For product quality, collaborates with Manufacturing Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the Quality Leadership decision.
  • For quality and compliance, collaborates with the Quality Leadership Team but accountable for creating a ‘right first -time’ culture in the Quality group to support quality excellence.
  • For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.

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.

Job ID SR0033552

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