QC Analyst

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 .

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

Do work that matters at CSL Seqirus!

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