Quality Officer (Maternity Cover - 12 -month FTC)
Location : On-site - Coleby House, Skipton, BD23 3AG
Salary : £29,300 - £36,500 per annum, DOE + Excellent Benefits!
Hours : 40 hours per week, Monday - Friday (8:00am - 4:30pm)
Contract Type : Full-time, Fixed-term (12 months)
Benefits : Annual Bonus : Up to £1,200 based on company and personal performance, Holidays : 25 days plus statutory holidays (option to purchase up to one additional week), Broughton Day : Fixed day off every 2-3 weeks via salary sacrifice, Pension : Auto-enrolment, Life Insurance : 2 salary death in service and Healthcare : Cash plan
Broughton's mission is to improve public health and well -being.
As a global contract research organisation, we collaborate with future-focused organisations and category innovators to bring products to market across the Pharmaceutical, Healthcare and Lifestyle sectors.
Our integrated solutions are delivered through our contract laboratories by a world-leading team of scientists and regulatory consultants.
At Broughton, quality is fundamental to how we operate. Our quality systems underpin the integrity of our data, the confidence of our clients and the standards we hold ourselves to as a regulated organisation.
We are seeking a Quality Officer on a FTC for 12 months to support the everyday operation of quality and compliance across Broughton during a period of maternity cover.
Reporting to the Quality Manager, you will play a key role in the delivery and maintenance of the Quality Management System (QMS), supporting GMP, ISO 17025 and non-GMP activities across the business.
This is a hands-on quality role suited to individuals who are comfortable working across documentation, investigations and audit activity, and who can apply regulatory requirements pragmatically within a commercial laboratory environment.
As our Quality Officer, you will be responsible for:
Owning assigned Quality Management System (QMS) processes, ensuring records are accurate, current and reviewed on time
Reviewing, approving and controlling quality documentation, including release records, deviations, non-conformances, validation documents, protocols and reports
Logging, reviewing, approving and supporting investigation of quality events, including deviations, OOS/OOTs, complaints, CAPAs, system suitability failures and equipment failures
Supporting internal inspections and client or regulatory audits, including preparation, back-room support, responses and follow-up actions
Maintaining quality logs, databases and documentation to ensure complete, accurate and contemporaneous records
Managing and responding to quality mailbox requests
Raising, reviewing and approving internal documentation supporting operational needs (e.g. static data changes and CDS template requests)
Conducting internal audits in line with approved schedules and procedures
Acting as a Subject Matter Expert within defined QMS areas, such as supplier approval, change control, validation or documentation
Supporting or leading investigations, including root cause analysis, risk assessments and CAPA ownership
Managing supplier and subcontractor approval activities, including risk assessments, audits and follow-up actions
Supporting quality agreements, contract acceptor processes and client-specific quality requirements
Planning, delivering and tracking continuous improvement initiatives arising from audits or internal review
Coordinating and tracking CAPAs to agreed timelines
To be successful in this role, you will need:
A degree or qualification in a scientific or vocationally related discipline
At least 2 years' experience working in a Quality role within a regulated environment
Working knowledge of relevant regulations and standards (e.g. GxP and/or ISO 17025)
Experience applying regulations to technical documentation, such as methods, validations, protocols and reports
Familiarity with investigation techniques (e.g. deviations, OOS/OOTs, non-conformances and CAPAs)
Strong attention to detail and commitment to data integrity
Clear, confident written and verbal communication skills
Good organisational skills with the ability to manage competing priorities
Competent IT skills, including Microsoft Office applications
A professional, collaborative approach when working across teams
It would be great if you also had:
Experience with quality improvement methodologies (e.g. Lean, Six Sigma, QbD)
Knowledge of chromatographic data systems and statistical tools
Experience supporting or leading audits
Strong technical writing skills and confidence providing review feedback
Demonstrable commercial awareness within a regulated environment
Join us and contribute to the systems and standards that underpin high-quality science and protect public health.
If you are interested in this role, please submit your CV by clicking APPLY.
Please note : We do not offer sponsorship.
No agencies please.
TPBN1_UKTJ