Document Control Administrator

JR United Kingdom; Stevenage; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading medical products and technologies company seeks a Document Control and Administrator. In this pivotal role, you will support quality systems and oversee document management while ensuring compliance with policies. The ideal candidate will possess strong organizational skills and a background in quality management.

Qualifications

• Experience with quality management systems, preferably ISO 13485.
• Proficiency with large document repository databases.
• Basic lab experience is a plus.

Responsibilities

• Ensure all quality documents are formatted and aligned with EDMS.
• Oversee document drafting, review, and approval for purchases.
• Manage office administrative duties including documentation.

Skills

Attention to detail

Team collaboration

Organizational skills

Time-management skills

Strong IT skills

Education

STEM-focused university degree or equivalent

Tools

Microsoft Word

Trackwise

Quality management systems

Job description

Job Title: Document Control and Administrator

Contract: Permanent

Location: Abingdon, Oxford

Job Description:

We are working on an exciting opportunity for a Document Administrator to join a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.

Job Summary:

Your role as a Document Controller and Administrator is to provide all Quality Systems administrative support to enable the Oxford team to smoothly transition into the business’s electronic document management system (EDMS). You will ensure that all quality documents and relevant records are in the correct format and templates for laboratory processes and support functions. You will liaise closely with the laboratory team to ensure document content is correctly captured. You will also work with the quality and business teams as well as project managers.

You will oversee all office administrative duties, including documentation drafting, shipping, purchasing supplies, maintaining inventories, and scanning lab books. Attention to detail and teamwork are essential.

Key Duties and Responsibilities:

• Ensure all quality documents are in the correct templates, formatted correctly, and aligned with the EDMS, adhering to document control procedures.
• Cross-check documents with existing quality documents.
• Assist with document drafting, review, and approval for equipment and software purchases.
• Link quality work instructions to SOPs with management and quality teams.
• Maintain smooth administrative operations in compliance with policies.
• Manage purchasing of reagents, consumables, and equipment.
• Coordinate on-site leadership meetings, including accommodation, transport, and catering.
• Review and optimize office policies and procedures, especially documentation and filing systems.

Experience Required:

• STEM-focused university degree or equivalent (desirable).
• Experience with quality management systems, preferably ISO 13485.
• Experience with Trackwise is highly desired.
• Proficiency with large document repository databases.
• Experience working with Regulatory, Validation, and QA teams is beneficial.
• Familiarity with User Requirement Specifications, Validation Plans, IQ/OQ/PQ, and 21 CFR Part 11 is advantageous.
• Strong IT skills, especially with Microsoft Word.
• Excellent organizational and time-management skills.
• Ability to prioritize tasks and work under pressure.
• Strong attention to detail.
• Basic lab experience is a plus.
• Team collaboration skills.