Analyst III, QC
CSL
Summary
Primary responsibilities for this position include performing tasks associated with raw material and product release in a GMP environment. This analyst will ensure that CSL Seqirus samples are testing according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory requirements. This role works standard business hours, Monday - Friday, onsite five days a week.
Job description
Job Purpose
Primary responsibilities for this position include performing tasks associated with raw material and product release in a GMP environment. This analyst will ensure that CSL Seqirus samples are testing according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory requirements. This role works standard business hours, Monday - Friday, onsite five days a week.
The Role
- Performs raw material compendia chemistry testing for QC Samples.
- Perform product testing related to chemistry tests for QC Samples.
- Performs GMP testing and associated tasks without errors per applicable SOPs and protocols.
- Comply with procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
- Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs.
Minimum Requirements
- Bachelor's degree in a Scientific discipline is required.
- Experience with HPLC/UPLC chromatography; Empower experience preferred.
- Experience testing with compendia (USP/EP) or knowledge of compendia.
- Knowledge of analytical methods and related instrumentation.
- Knowledge of GMPs, laboratory documentation, and data integrity.
- One year of relevant industry experience required.
- GLIMS Labware experience.
Requirements
- Bachelor's degree in a Scientific discipline is required.
- Experience with HPLC/UPLC chromatography; Empower experience preferred.
- Experience testing with compendia (USP/EP) or knowledge of compendia.
- Knowledge of analytical methods and related instrumentation.
- Knowledge of GMPs, laboratory documentation, and data integrity.
- One year of relevant industry experience required.
- GLIMS Labware experience.
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.