QC Analyst (Analytical Chemistry) (12 month FTC)

at  CSL Behring

This role is for an Analyst within the Analytical and Raw materials laboratory, within Quality Control. It is a fast paced, high through put 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 effected 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

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 effected 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