Document Control Administrator

JR United Kingdom; Newport; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading global medical products company is seeking a Document Control and Administrator to ensure quality systems documentation is maintained effectively. This desk-based role involves close collaboration with teams to transition to an electronic document management system, oversee administrative duties, and ensure compliance with quality standards.

Qualifications

• University Degree in a STEM field is desirable.
• Experience with quality management systems, ideally ISO 13485.
• Strong IT skills and proficient in Microsoft Word.

Responsibilities

• Provide all Quality Systems administrative support.
• Ensure all quality documents are correctly formatted.
• Manage on-site leadership meetings and associated logistics.

Skills

Organisational skills

Attention to detail

Collaboration

Education

STEM focussed University Degree (or equivalent)

Tools

Microsoft Office Suite

Trackwise

Job description

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• Job Title: Document Control and Administrator
• Contract: Perm
• Location: Abingdon, Oxford

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 required relevant records are in the correct format and templates for laboratory processes and support functions to work effectively. Although this a desk-based role, you will liaise closely with the laboratory team to ensure document content are correctly captured. You will also work with the quality and business teams as well as project managers.

You will also have a solid track record of successful administrative work and oversee all office administrative duties which will include ownership of ancillary roles including, but not limited to, documentation drafting, shipping, purchasing supplies, maintaining office inventories and scanning lab bench books and lab logbooks. You will be thorough and pay attention to detail and can work well with the team.

Key Duties and Responsibilities

• Ensure all quality documents, including, but not limited to Work Instructions, Technical Documents and SOPs, are in the right templates are formatted correctly and align with the company EDMS whilst adhering to procedures for Document Control.
• Cross-check 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, 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.

Experience required

• STEM focussed (desirable) University Degree (or equivalent)
• Have experience with working in or with a quality management system, preferably to ISO 13485.
• Trackwise experience is highly desired
• 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.
• 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.