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Sr Associate Quality Control Dublin Ireland,  

Amgen (company)


Posted on : 01 May 2017

Project Description


Key Responsibilities
  • Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. 
  • Experience with liquid-handling robots is also preferable.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Participate in the peer review of analytical data.
  • Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
  • Lead training of staff on technical aspects of job as required. 
  • Develop, revise and implement procedures that comply with appropriate regulatory requirements.
  • Qualification of analytical equipment and related testing functions.
  • Participate in Analytical Method Transfers
  • Compliance with Standard Operating Procedures and Registered specifications.
  • Ensure the laboratory is operated in a safe manner
  • Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
  • Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
  • Participate in the generation and update of SOP s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
  • Participate in regulatory agency inspections as required.
  • Plan and implement procedures and systems to maximise operating efficiency.
  • Manage and contribute to the achievements of department productivity and quality goals.

Locations

Ireland Dublin

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