Senior Quality Control Analyst
Aegros Therapeutics Pty Ltd, Australia
Job Description
About Aegros
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collect into life saving hyperimmune products.
About the role
We are seeking a trained person to join our quality control and assurance to develop and perform microbiological, chemical and biochemical analysis of In process, Finished product and incoming raw materials and utility samples.
Key Responsibilities include:
- Conduct QC testing in accordance with approved procedures.
- Testing of raw materials, production, stability samples, Ramp;D Samples and adhoc QC samples.
- Checking of assays, result entry and verification of assay paperwork.
- Ensuring that safe environment is maintained at all times
- Maintenance of QC documentation and training records.
- Ensure all samples in the QC laboratory are documented as per approved procedures
- Accurately completing all documentation.
- Assist in updating and reviewing documentation (SOP’s, Test methods and Specifications)
- Validation and qualification of analytical test methods and equipment qualification
- Support the team to ensure that the testing performed in each department are prepared and executed in accordance with GMP
- Assisting in technical issues and trouble shooting. Assist in root cause analysis and implement CAPA.
- Calibrating and maintaining laboratory equipment
- Ordering and maintaining stock of reagents, consumables
- Prioritizing workload to meet the required turnaround times
- General housekeeping and maintaining OH amp; S
- Handling of Investigations and Deviations
- Assisting in training when required
- Being a part of Regulatory and Internal audits as per the requirement
- Any additional duties as assigned
Requirements
To be the successful applicant for this great opportunity you will be tertiary qualified in biological science or related discipline with at least 3 years QC experience or laboratory experience either in research, pharmaceutical, diagnostic or food industry and strong proven background and knowledge in GMP environment. Knowledge of Protein chemistry and associated analytical biological assays and the knowledge of biological separation technologies and processes are desired but not essential.
You must be able to communicate well in spoken and written word and be a highly motivated and pro-active self-starter. Position may require to wear aseptic gowning.
If you have the skills and experience to successfully carry out the requirement of the role, we would like to hear from you!
Apply now for this great opportunity, including your updated CV!
Benefits
- Supportive and friendly team
- Rewarding culture
- Weekly Fruits
- Birthday Celebration