The purpose of the QC Incoming and Components Analyst role is to compliantly perform Primary QC inspection, Sampling of raw materials, components laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs) for all primary and secondary packaging components. QC Incoming and components analysts will be required to support release of raw materials and components for use in manufacture. QC incoming and component’s Analysts may also be required to participate in technical and validation studies in support of both departmental and site objectives.
The primary responsibilities of a QC Incoming and Components Analyst is to compliantly perform component 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.
In addition to testing, Analysts will be required to perform raw material and components inspection (quality receipt) and raw material and component sampling.
It is the responsibility of QC Incoming and Components Analysts to communicate their findings as a result of testing/inspections 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.
It is the responsibility of QC Incoming and Components Analysts, when assigned, to complete critical tasks such as:
1. Instrument Maintenance and Calibration
2. Sampling booth cleaning and monitoring
3. Initiation of deviations
4. Initiation, and completion, of CAPAs
5. Completion of Change Control actions
6. Updates and reviews of SOPs
7. Participation in quality risk assessments
It is the responsibility of QC Incoming and Components Analysts to participate in laboratory administration tasks such as:
8. HSE risk assessment completion, review and adherence
9. Archiving of laboratory documentation,
10. Ordering of materials and consumables
11. Maintenance of QC sample and reagent stores
12. Ensuring a clean and safe workplace for all associates
It is the responsibility of QC Incoming and Components 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 Incoming and Components Analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC Analytical leadership team.
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 fluent in English as the primary operating and reporting language used within the industry, in addition they must:
13. Have experience in QC testing techniques appropriate to their role
14. Have experience in cGMP application
15. Have an awareness of the requirements for equipment and method validation
16. Have awareness of root cause analysis
17. Be computer literate and be able to demonstrate an understanding of electronic systems
This position is also available to Internal employees as a potential 12 month secondment opportunity
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.