CSL - Australia

Sterility Assurance Senior Specialist

18 Feb 2021
20 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
About CSL

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!

Job Description

The Opportunity

We are seeking an experienced Senior Sterility Assurance Specialist to join our dynamic team in our Quality Assurance function in Parkville (Australia).This exciting role is responsible for ensuring that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOP's, the Quality Manual and Good Manufacturing Practice. You will also provide sterility assurance support and training for the Seqirus Parkville site as well as all third-party facilities that perform manufacturing activities on behalf of Parkville.

The Role

Reporting to the Sterility Assurance site lead your responsibilities will include:
  • Performing quality risk assessments reviews for environmental monitoring programs.
  • Responsible for drafting appropriate technical documentation, ensuring that the content complies with GMP, internal and regulatory obligations.
  • Completing annual reports, reviews, risk assessments & trending for evaluating current manufacturing monitoring programs.
  • Perform manufacturing investigations related to microbiological excursions & deviations.
  • Deliver continuous improvement processes to improve sites aseptic behaviour & technique standards

The successful candidate must have:
  • Bachelor's degree in a related discipline - Microbiology (preferred) , Biochemistry, Pharmaceutical Sciences;
  • Minimum of 5 years' GMP experience in pharmaceutical/biotech/or other regulated industry;
  • Good understanding of aseptic manufacturing techniques - Grade A or B;
  • Understands Quality Control testing and industry practices;
  • Can work independently and has proven time management skills for planning and scheduling work;
  • Maintains knowledge of regulatory agency requirements and expectations and Seqirus Quality Manual;
  • Is an effective communicator both written and verbal with the confidence and ability to present and train others;
  • Has excellent 'people skills' and is able to influence, persuade and provide clear direction in relation to sterility across the organisation.

How to apply

If this sounds like you and you are looking to further develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-130045

Applications will close 5pm AEST on 9th March 2021

CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process. Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies.

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