The purpose of the QC 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 finished vaccine products.
QC Analysts are also required to participate in technical and validation studies in support of both departmental and site objectives
Responsibilities include: -
The primary responsibility of a QC 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 EHS. The duties of a QC analyst will be focused on QC release testing of Finished product during the Northern Hemisphere season. The scope of Analytical testing will vary in accordance with departmental and Organisational needs, outside the season.
Communicate their findings as a result of testing promptly, to the QC Analytical 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.
To complete critical tasks such as:
Instrument Maintenance and Calibration
Actions required for the Temperature Monitoring system
Reagent and Standard Qualification
Initiation of deviations
Initiation, and completion, of CAPAs
Completion of Change Control actions
Updates of SOPs
Participation in quality risk assessments
Participate in laboratory administration tasks such as:
EHS 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
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
Ensure that they communicate professionally and effectively with their fellow team members and QC leadership.
Qualifications, Skills and Competencies: -
QC Analysts must be educated to tertiary level in a relevant scientific discipline OR Other qualification in combination with appropriate industry experience
2-3 years’ experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard
Must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:
Experience in QC testing techniques appropriate to their role
Experience in cGMP application
Awareness of the requirements for equipment and method validation
Awareness of root cause analysis
Must be computer literate and be able to demonstrate an understanding of electronic systems
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
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QC Analyst