QC Bioassay

Adecco Portugal; Liverpool; On-site; GBP 47,000 - 52,000; Full time

Job summary

The QC Analyst role based on site in Speke, Liverpool, is responsible for compliant QC testing, data review and interpretation per SOPs for vaccine-related materials.

Responsibilities include communicating findings to the QC leadership team, handling deviations, and contributing to CAPAs, change controls and SOP updates while adhering to EU GMP and HSE standards. English fluency is required.

Qualifications

• Experience performing QC testing in a regulated environment.
• Knowledge of cGMP requirements and compliance expectations.
• Awareness of equipment and method validation concepts.
• Ability to identify and analyze deviations and root causes.

Responsibilities

• Perform QC laboratory testing on in-process, intermediate and finished products.
• Conduct data review and interpretation in line with SOPs.
• Communicate test results and deviations to leadership promptly.
• Participate in CAPAs, Change Controls and SOP updates as required.
• Support quality risk assessments and equipment maintenance tasks.

Skills

QC testing techniques

cGMP

Equipment validation

Root cause analysis

Computer literacy / electronic systems

Job description

£22.77 Shift 5 on 3 off (hours 8-5 , 5 on 3 off 12 Month Contract )

Based on Site in Speke - Liverpool

The purpose of the QC Analyst role is 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.

The primary responsibility of a QC Analyst is to 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.

In addition to testing, Analysts will be required to perform raw material and components inspection (quality receipt) and sampling.

It is the responsibility of QC Analysts to communicate their 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

It is the responsibility of QC Analyst, when assigned, to complete critical tasks such as:

It is the responsibility of QC Analyst, when assigned, to 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

QC Analysts must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:

• 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