Quality Assurance Officer

Kedrion Biopharma GmbH; Elstree; On-site; GBP 40,000 - 50,000; Full time

Job summary

A biopharmaceutical company in Elstree is seeking a Quality Assurance Officer to manage compliance within a regulated environment. The role involves acting as the primary QA contact, managing quality incidents, and conducting audits. Strong knowledge of Quality Management Systems and experience in sterile environments are necessary. This is a 24/7 position, providing a dynamic opportunity for professional growth within an international company committed to patient safety and product quality.

Benefits

Pension

Life Insurance

On‑site parking

Subsidised canteen

Employee discounts and cash back

Family friendly policies

Employee recognition programme

Qualifications

• Experience working in a regulated quality environment.
• Understanding of GMP and GxP requirements.
• Competent with root cause analysis and error risk reduction tools.

Responsibilities

• Act as the primary Quality Assurance contact across site during the shift.
• Manage quality incidents and deviations using TrackWise.
• Conduct QA walk rounds, audits and inspections across manufacturing.

Skills

Experience in sterile aseptic filling and packaging environments

Familiarity with TrackWise and LIMS systems

Knowledge of UK/EU and US regulatory requirements

Experience with continuous improvement tools and methodologies

Excellent attention to detail

Strong knowledge of Quality Management Systems

Confident communicator

Ability to work cross-functionally

Education

Degree-level qualification in a scientific discipline

Tools

TrackWise

Job description

Kedrion Biopharma is recruiting a Quality Assurance Officer (QAO) to join our Quality Assurance Operations team at our Elstree site. This is an excellent opportunity to take on a hands‑on, site‑based QA role within a highly regulated biopharmaceutical manufacturing environment.

Reporting to the QA Operations Shift Lead, you will act as the primary QA contact on shift, working closely with Manufacturing, Engineering, and Technical teams to ensure ongoing compliance with GMP requirements and site quality systems. The role offers broad exposure across operational উপস্থিত areas and plays a key part in supporting day‑to‑day manufacturing activities.

This role is on a 24/7 shift and the hours are – 4 days on (7am to 7pm) and 4 days off, then 4 nights on (7pm to 7am) and 4 nights off working Monday to Sunday.

Duties & Responsibilities

• Act as the primary Quality Assurance contact across site during the shift
• Manage quality incidents and deviations using TrackWise, including DRs, QIs and CAPAs
• Review and approve documentation, ensuring completeness and compliance
• Perform prompt review of Batch Process Records and Autoclave Batch Processing Records
• Conduct QA walk rounds, audits and inspections across manufacturing and support areas
• Perform QA AQL sampling for finished product inspection
• Support investigations, root cause analysis and error risk reduction activities
• Escalate product quality or patient safety concerns to QA Management as required
• Participate in regulatory, customer and internal audits
• Maintain accurate QA records and contribute to continuous improvement initiatives

Skills & Education to help you in the role

• Experience in sterile aseptic filling and packaging environments
• Familiarity with TrackWise and LIMS systems
• Knowledge of UK/EU and US regulatory requirements
• Experience with continuous improvement tools and methodologies
• Degree-level qualification in a scientific discipline (or equivalent experience)
• Experience working in a regulated quality environment
• Strong knowledge of Quality Management Systems (deviations, CAPAs, root cause analysis)
• Understanding of GMP and GxP requirements
• Excellent attention to detail, organisational and time‑management skills
• Confident communicator with the ability to work cross‑functionally
• Competent with root cause analysis and error risk reduction tools
• Able to enter production facilities and work a 24/7 shift pattern

What We Offer

If you are looking for an opportunity to join a growing international biopharmaceutical company working within a role supporting patient safety and product quality, with ongoing training and professional development then we’d love to hear from you.

• Pension
• Life Insurance
• On‑site parking
• Subsidised canteen
• Employee discounts and cash back
• Family friendly policies
• Employee recognition programme

Please apply now for immediate consideration.