Quality Assurance Officer

Reference Number: JO-2502-548167
Quality Assurance Officer
Rate: Negotiable
Job Type: Permanent
Location: Elstree, Borehamwood

Job Title: Quality Assurance Officer – Shift based role

Job Type: Permanent Position, shift based

Location: Elstree, Hertfordshire, UK.

Salary and Remuneration: £38,080 /experienced hires with relevant experience up to £43,130 + £7,800 shift allowance

I have an exciting opportunity for a Quality Assurance Officer to join a growing Rare Disease Plasma Biotech based in Hertfordshire. This role will report to the QA Manager and will assist all departments across site (primarily Production, Engineering and Technical) in prompt handling of quality incidents and deviations using Trackwise.

Shift Details: 24/7 shift – 4 days on, 4 off, 4 nights on, 4 off – 12 hour shifts – 7am – 7pm and 7pm to 7am (Monday to Sunday). Candidates MUST drive/have a vehicle/bike etc and be able to get to site as there are no public transport links close by.

Role Purpose:

1. To assist all departments across site (primarily Production, Engineering and Technical) maintain compliance to quality systems through auditing, training as required.
2. To assist in prompt review of Batch Process Records.
3. Primary QA contact throughout the shift and perform walk rounds throughout various departments ensuring quality is maintained across the facility.

Main Responsibilities:

1. To be primary QA contact across site throughout shift, discerning what is potentially a major or critical deviation.
2. Receive, review and process quality reports on Trackwise (eg DR/QI/CAPA records) according to defined procedures.
3. Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required.
4. Ensure that any documents presented for QA approval/checking are complete.
5. Ensure a standard approach to quality systems throughout the facility, by undertaking both internal quality audits and QA inspections of facilities and activities, for departments across site.
6. Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including QA Management.
7. To co-ordinate and maintain the files for a range of quality records as required.
8. To perform QA AQL sampling for Finished Products Inspection.
9. Review Autoclave Batch Processing Records.
10. To perform regular audits of the manufacturing facility and contribute to continuous improvement activities.
11. To participate as required in Regulatory and customer audits.
12. To undertake work related to job objectives as directed by QA management.

Requirements:

1. Degree level qualification in science discipline or equivalent.
2. Experience of working within regulated Quality environment.
3. Knowledge, understanding and experience of Quality Management Systems including CAPA’s, Deviations and Root Cause Analysis.
4. Understanding of GMP and GxP.
5. Knowledge of sterile aseptic filling and packing manufacturing processes is desirable.
6. Experience of working with TrackWise and LIMs desirable but not essential.
7. Knowledge of UK/EU and US Regulatory requirements desirable.
8. Competent with using root cause analysis and error risk reduction tools essential.
9. Knowledge of continuous improvement tools and methodologies desirable.
10. Capable of entering production facility (change procedure) essential.
11. Ability to work 24/7 shift pattern essential.
12. Must be able to work cross-functionally across the business.

The role is an excellent opportunity to work within an innovative environment with great career progression opportunities. If you are interested in this role or would like more details, please email your CV to

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