Quality Control Chemist

Quality Balcatta, WA


Descripción

About the role

To ensure the Quality and Compliance of raw materials, bulk and finished products by carrying out daily activities including analytical testing and documenting relative to the support of Perrigo Australia’s operations and manufacturing needs according to cGMP requirements.

In addition to perform complex calibrations, troubleshoot tasks and repairs, testing variance investigations, identify and implement corrective actions or process improvements, document change control activities and write test methods.

This position is on a weekly rotational roster, 7:00am – 3:30pm and 9:00am – 5:30pm

Duties

  • Conducts complex testing and documenting of raw materials, bulk and finished products (including stability samples) according to established methods and to ensure conformity to specifications while meeting scheduling requirements
  • Initiates, investigates and completes laboratory investigations with the support of the QC Supervisor
  • Conducts and participates in training and development.
  • Develop and investigate analytical methods for finished products and raw material testing
  • Performs and documents routine calibration of laboratory instruments and QC In Process Checks
  • Maintain laboratory processes and systems in accordance with cGMP requirements (including data integrity)
  • Writes test methods, procedures and technical reports
  • Maintains personal laboratory work area and assists with general laboratory cleaning
  • Perform all laboratory related tasks in accordance with established site OH&S requirements
  • Contribute to continuous improvement initiatives in both the laboratory and across site

Skills & Experience

  • Bachelor’s degree with a minimum of 2-4 years’ experience in a laboratory setting in a GMP environment
  • Demonstrated mechanical aptitude, with troubleshooting, data analysis and investigational skills
  • Competency in HPLC/GC analytical methodologies
  • Excellent communication and documentation skills and the ability to work in a team environment
  • Strong technical writing skills
  • Understanding cGMP/GLP requirements for all data generated by the QC laboratory.
  • Strong attention to detail and the ability to follow written procedures
  • Competency with Microsoft Office®
  • Experience with Empower® chromatography software will be highly regarded
  • Experience with continuous improvement processes will be highly regarded