Analyst II/III, QC (Microbiology)
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. Secondary responsibilities include cross training of staff. The analyst will be responsible for ensuring that Seqirus samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.Major Accountabilities
- Performs testing and associated tasks without errors per applicable SOPs and protocols.
- Complies with policies and procedures in order 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
- Performs shift-work as necessary to support manufacturing Participates and performs in cross-training to support staff availability within QC department
- Develops and maintains SOPs
- Develops expertise in assigned assays/techniques
- Authors deviation and invalid assay assessments
- May be required to perform shift work as required to support operations
- Bachelors degree or Associate’s degree and 5+ years of industry experience or equivalent.
- Minimum of 3 years of laboratory experience OR equivalent.
- Knowledge of GMPs, safety regulations and data integrity preferred.
- Knowledge of analytical methods and related instrumentation.
- LIMS experience preferred.
- Prefer experience with sterility testing, EM, water and clean steam collection, and gas sampling.
- Method verification/validation experience (sterility, endotoxin, bioburden, and AET) preferred.
- Other technical competencies: Bioburden testing, endotoxin testing (preferably Kinetic method), growth promotion testing of microbiological media, identification of microbiological isolates, antimicrobial effectiveness testing (AET) and EM trending