Quality Assurance Specialist Document Control

Location

San Diego, US

Job Type

Company Overview

LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.

Role & Responsibilities

Quality Assurance (QA) Specialist - Document Control - Site based at our sites in San Diego 

The Opportunity

The Quality Assurance Specialist – Document Control shall support the ongoing development and effectiveness of the site quality system ensuring documentation and systems comply with the applicable standards and regulations for medical devices and in-vitro diagnostics. Additional responsibilities include maintaining Change Control, Training, External Documents/Standards, and performing ERP updates.

The Role

    Document Control/Quality Systems

    • Support internal/external audits and inspections.
    • Create and revise departmental SOPs and Work Instructions, as requested
    • Scan, inventory, archive and retrieve quality documents and records.
    • Perform Other Quality System duties as assigned.

    Change Control

    • Support the coordination, preparation, formatting, review, approval and implementation of controlled documents via the Change Control system in GAS.
    • Provide guidance to authors, reviewers and approvers in a positive and collaborative manner to ensure documents are routed, reviewed, approved and published in a timely manner.
    • Ensure documents are formatted in line with relevant SOPs and regulating standards.
    • Coordination of Document control activities including document filing, maintaining Master logs.
    • Control access to effective, draft and obsolete documents; maintain document history files.
    • Support the biennial review of controlled documents.

    Training

    • Responsible for Training Administrator activities.
    • Provide support to LumiraDx site training program.
    • Maintain training records and documentation; run reports as needed.
    • Add/remove training requirements for new/obsolete documents.
    • Enter new/updated training requirements into GAS.
    • Scan and enter completed paper training records into GAS.
    • Add/remove new and inactive employees in GAS.
    • Assist with the annual Training Matrix review.

    External Documents and Standards

    • Assist with the maintenance of the External Documents and Standards master list.
    • Support the biennial review of External Documents and Standards.

    Required Experience

    About You:

    We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem-solving and communication, along with the following experience:

    • High school diploma required; Bachelor’s degree preferred
    • One (1) to three (3) years’ related relevant experience required.
    • Quality experience in a Good Manufacturing Practice (GMP) regulated environment desired.
    • Prior exposure/experience in records management for a medical device/diagnostics or pharmaceutical company preferred.
    • Experience/working knowledge of relevant regulations applicable to the control of documents/records and training in an ISO/FDA regulated company.
    • Prior exposure/experience with an Electronic Document Management Systems (EDMS) is preferred.
    • Experience with an Enterprise Resource Planning (ERP) system desired.
    • Experience of working in a medical device design environment with a strong quality focus
    • Excellent organizational, oral and communication skills
    • Demonstration of good problem-solving abilities
    • Ability to manage multiple tasks and remain flexible to changing priorities
    • Ability to complete projects and assignments efficiently and appropriately

     

    For further information and to apply for this role, please click APPLY

    APPLY

    Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security.