Qc Analytical Specialist

1 week ago


Melbourne, Victoria, Australia Bell People Consultants Full time
Global Pharmaceutical Manufacturing Organisation

  • Excellent Long Term Contract Opportunity
  • Melbourne Metropolitan Area

About the Company


Operating as a major global Multinational pharmaceutical manufacturer with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace, offering a range of healthcare products to local & global markets.

Due to increase in project requirements within the quality team, our client is now seeking a

QC Analytical Specialist with experience in HPLC & performing laboratory procedures including release testing assays for clinical trials (Phase 1 & Phase 2)& method development and validation within a cGMP environment.

About the Opportunity

Key responsibilities include the following:

  • Perform routine GMP product release testing in support of Phase 1 / 2 Clinical Manufacture.
  • Maintain laboratory quality systems and records of analytical results.
  • Write & review experimental data packages, analytical documents & reports in accordance with regulations & guidelines.
  • Contribute to quality system change controls & deviations.
  • Support analytical method qualification & method transfer on HPLC.
  • Support equipment & software qualification & validation.
  • Effectively liaise with internal stakeholders at all levels.

About You

  • Tertiary qualifications in Science.
  • Experience in qualification & transfer of methods for early phase clinical trials.
  • Sound experience with HPLC, capillary electrophoresis & plate based assays.
  • Specific experience working in a GMP environment.
  • Knowledge of ELN, instrument software. electronic quality systems & LIMS.
  • Motivated individual with a strong commitment to quality & time management.
  • Proactive, well organized with sound interpersonal skills.
  • Sound written & verbal communication skills.

Culture & Benefits
This is an excellent contract opportunity for a

talented and self motivated QC Analytical Specialist with experience in HPLC, method validation & development to join a leading global pharmaceutical manufacturing organisation & be involved in HPLC & testing assays for clinical trials, method development & validation.

How to Apply

CV in MS Word.
For confidential discussion, you can contact Sue Campbell on
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