QC Analyst (Level 2)

United KingdomR-1073600605 Seqirus Vaccines Limited

About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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 purpose of the QC Bioassay analyst role is to compliantly perform QC laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs). Analysis is performed on in-process, intermediate and finished vaccine products. QC Bioassay analysts are also required to participate in technical and validation studies in support of both departmental and site objectives.

The primary responsibility of a QC Bioassay analyst is to compliantly perform laboratory testing, data review and data interpretation in accordance with approved SOPs. It is expected that analysts consistently work to the highest standards of cGMP (as defined in the EU GMP Annexes and FDA CFRs) and in accordance with the uppermost standards of HSE.

It is the responsibility of QC Bioassay analysts to communicate their findings as a result of testing promptly, to the QC Bioassay leadership team (Team Coordinators and Manager). Specifically, it is expected that deviations (either out of specification results or compliance gaps) are highlighted to a leadership team member immediately as they are recognised.

It is the responsibility of QC Analyst, when assigned, to complete critical tasks such as:

  • Instrument Maintenance and Calibration
  • Reagent and Standard Qualification
  • Initiation of deviations
  • Initiation, and completion, of CAPAs
  • Completion of Change Control actions
  • Updates and reviews of SOPs
  • Participation in quality risk assessments

It is the responsibility of QC Bioassay analysts to participate in laboratory administration tasks such as:

  • HSE risk assessment completion, review and adherence
  • Archiving of laboratory documentation,
  • Ordering of reagents and consumables
  • Maintenance of QC sample and reagent stores
  • Ensuring a clean and safe workplace for all associates

It is the responsibility of QC Bioassay analysts to proactively maintain their own training records, and to only perform tasks that they have confirmed themselves to be compliantly trained in, in accordance with local SOPs

It is the responsibility of QC Bioassay analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC Bioassay leadership team.

Knowledge, Skills & Competencies

QC Analysts must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:

  • Have experience in QC testing techniques appropriate to their role
  • Have experience in cGMP application
  • Have an awareness of the requirements for equipment and method validation
  • Have awareness of root cause analysis
  • Be computer literate and be able to demonstrate an understanding of electronic systems

Minimum Education Requirements

QC Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific discipline

Minimum Experience Requirements

QC Analysts must be have experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard