Our client a global biotech company based in Speke are looking for a QC Analyst to join their QC Bioassay team 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, raw materials, components and utilities samples. QC Analysts are also required to participate in technical and validation studies in support of both departmental and site objectives.
This is a temporary role for 12 months to start on the 24th May - Shifts = 5 days on 3 days off.
- 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.
- Perform raw material and components inspection (quality receipt) and sampling.
- Communicate 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.
- Complete critical tasks such as:
- Instrument Maintenance and Calibration
- Sampling booth cleaning and monitoring
- 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
- 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
- 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
- Communicate professionally and effectively with their fellow team members and the QC Analytical leadership team.
- 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
- Educated to NVQ level 2 or equivalent in a relevant scientific discipline
- Must have experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard
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