Document Controller

SRG; Oxford; On-site; GBP 25,000 - 30,000; Full time

Job summary

A leading company in Oxford is seeking a Document Controller to manage quality documentation and ensure compliance with procedures. This permanent role involves liaising with quality teams, overseeing document control, and ensuring day-to-day administrative operations run smoothly. Ideal candidates will have experience with quality management systems, strong organisational skills, and attention to detail.

Qualifications

• Experience working in ISO 13485 environments preferred.
• Knowledge of User Requirement Specifications and Validation Plans beneficial.
• Basic lab experience is an advantage.

Responsibilities

• Ensure all quality documents are correctly formatted and aligned with EDMS.
• Cross-check documents with existing quality documentation.
• Draft and review documents for equipment and software purchases.

Skills

Experience with quality management systems

Navigating document repository databases

Collaboration skills

Organisational skills

Attention to detail

Tools

Microsoft Office Suite

Job description

Job Title – Document Controller

Location – Abingdon, Oxford

Contract Length – N/A – perm

Pay Rate – approx. 30k

Key Responsibilities:

• Ensure all CTEC-Oxford quality documents, including, but not limited to Work Instructions, Technical Documents and SOPs, are in the right templates are formatted correctly and align with EDMS whilst adhering to procedures for Document Control.
• Cross-check CTEC-Oxford documents with pre-existing quality documents.
• Provide document drafting, review and approval as part of equipment and software purchase and implementation.
• With the help of management and quality teams link quality work instructions to pre-existing SOPs.
• Ensure smooth day-day administrative operations at CTEC Oxford team, in compliance with policies and regulations.
• Take ownership of purchasing reagents, consumables, and equipment.
• Arrange and manage on-site leadership meetings and coordinate all associated accommodation, transport and catering.
• Review and optimize office policies and procedures٫ particularly documentation and filing systems.

Skills & Experience:

• Have experience with working in or with a quality management system, preferably to ISO 13485.
• Are adept at using and navigating large document repository databases.
• Having worked in/with Regulatory and Validation teams and QA would be beneficial.
• Having drafted User Requirement Specification, Validation Plans and be aware of IQ/OQ/PQ and 21 CFR Part 11 would be advantageous.
• Strong IT skills and knowledge of Microsoft Office Suite, principally, Word.
• Excellent organisational and time-management skills.
• Excellent record keeping skills.
• The ability to prioritise tasks and work under pressure.
• Strong attention to detail.
• Having basic lab experience would be an advantage.
• Strong collaboration skills and experience of working within a team.