Senior QC Associate (Cell Culture)
6d ago

The Role

  • 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
  • The Person

  • Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
  • Have 4-5 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.
  • Excellent written and verbal communication skills
  • Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
  • Knowledge of applicable Regulatory requirements
  • Experience with Regulatory inspections and interaction with inspectors is preferable
  • Experience leading cross-functional teams
  • Experience working with teams and influencing decision
  • Skilled in the use of problem-solving tools / techniques
  • Apply
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