Senior QC - Bioassay

Competitive
Permanent
Dublin
16 Jan 2020
BBBH750971

An opportunity for an experienced QC Analyst (with Bioassay exp) to move into a senior role with a global Biopharma.

Key Responsibilities

  • Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) 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.

Knowledge and Experience:

  • Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
  • Have 1.5 - 5 years of experience in a pharmaceutical/healthcare Laboratory.
  • Experience in Bioassays, Immunoassays and Cell Culture is essential.
  • Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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