21.75 hours – flexible days
Salary - £16,799 - £19,199 Depending on experience
Location – Starna Scientific, 52-54 Fowler Road, Hainault, Essex, IG6 3UT Role Purpose – Job Description
The Regulatory Compliance Questionnaire Assistant provides essential support to the Laboratory teams by completing, coordinating, and maintaining regulatory questionnaires and documentation required for GLP, GMP, ISO 17025, ISO 17034, ISO 9001, and compliance. The role ensures that all responses are accurate, audit compliant and aligned with internal procedures and external regulatory expectations.
This position is ideal for someone with a strong understanding of regulated laboratory environments who enjoys structured documentation work and has excellent attention to detail.
Key Responsibilities
* Complete regulatory questionnaires for clients, suppliers, accreditation bodies, and auditors.
* Interpret GLP/GMP/ISO requirements to ensure responses are accurate and compliant.
* Gather information from technical teams including calibration, laboratory, and QA colleagues.
* Review calibration certificates, equipment logs, and traceability records to support questionnaire responses.
* Maintain and update controlled documents, SOP references, and supporting evidence.
* Ensure all documentation meets ALCOA+ data integrity principles.
* Prepare and organise supporting attachments (e.g., training records, calibration reports, quality certificates).
* Track and log questionnaire response deadlines to ensure timely submission.
* Support internal and external audit preparation by ensuring documentation is complete and accessible.
* Maintain confidentiality and handle sensitive compliance information appropriately.
Skills, Knowledge & Experience
* Understanding of GLP, GMP, ISO 17025, ISO 17034 and ISO 9001 or similar regulatory frameworks.
* Experience working in a laboratory, calibration, or pharmaceutical environment (desirable).
* Strong documentation and organisational skills.
* Ability to interpret technical and regulatory questions.
* High attention to detail and accuracy.
* Confident communicator able to liaise with technical and QA colleagues.
* Familiarity with controlled document systems
* Competent in Microsoft Office (Word, Excel, Outlook).
Personal Attributes
* Methodical and structured approach to work.
* Proactive, reliable, and able to work independently.
* Comfortable handling repetitive or detailed tasks.
* Strong sense of responsibility for accuracy and compliance.
* Professional, discreet, and aligned with quality driven culture
Salary description
£16799.00 - £19199.00 per year