QC Analyst (Analytical Chemistry) (12 month FTC)
This role is for an Analyst within the Analytical and Raw materials laboratory, within Quality Control. 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 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 Co-Ordinator/Laboratory Manager and initiation of deviations in a timely manner.
* Escalate any OOS/OOE/OOT results to Team Co-Ordinator/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:
QC Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific discipline. Undergraduate (BSc) degree in Chemistry is preferred.
Minimum Experience Requirements:
QC Analysts must have experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP.
Minimum 1 year experience in Analytical Chemistry department.
Please note this role is a 12 month Fixed Term Contract.
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