Senior QC BioAnalytical Associate

  • Nationwide
  • Temporary 12 months
  • JO-1711-63042_1511889817

Summary

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.

Requirements
* Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
* Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
* Strong background 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

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