QC Specialist

1 week ago

Liverpool, Liverpool, United Kingdom CSL Seqirus Full time

This role is for an Analyst within the Analytical and Raw materials laboratory, within Quality Control at CSL Seqirus. It is a fast-paced, high-throughput laboratory where compliance with health authority regulations and attention to detail is critical to support the vaccine manufactured onsite.

Responsibilities:

  • Collection of samples from various manufacturing areas and receipt into the laboratory via the GLIMs system.
  • Work to a high level of cGMP and GDocP in order to maintain compliance and adherence to regulations.
  • Perform analytical testing of raw materials, in-process, finished product, and utilities samples in accordance with relevant SOPs.
  • Record and report laboratory analysis in a clear and concise manner ensuring compliance to regulations.
  • Perform thorough peer review of analysis to ensure accuracy and adherence to GMP/GDocP.
  • Instrument Maintenance and Calibration
  • Reagent and Standard Qualification
  • Escalation of issues to Team Coordinator/Laboratory Manager and initiation of deviations in a timely manner
  • Escalate any OOS/OOE/OOT results to Team Coordinator/Laboratory Manager as soon as practically possible.
  • Initiate and perform laboratory investigations with discussion and collaboration with affected departments where necessary.
  • Initiate and participate in the completion of CAPAs.
  • Complete relevant change control actions where necessary
  • Perform periodic reviews of SOPs
  • Participation in quality risk assessments
  • Completion of HSE risk assessments, periodic reviews, 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
  • Completion of training to maintain compliance
  • Participation in technical/validation studies where applicable.

Minimum Education Requirements

Quality Control Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific discipline. An undergraduate (BSc) degree in Chemistry is preferred.

Minimum Experience Requirements

Quality Control Analysts must have experience in the relevant testing discipline, ideally within the pharmaceutical industry, having worked to cGMP.

Minimum 1 year experience in an Analytical Chemistry department.

Please note this role is a 12-month Fixed Term Contract.

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 value diversity and inclusion at CSL Seqirus.

Do work that matters at CSL Seqirus

Watch our 'On the Front Line' video to learn more about CSL Seqirus.

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