Quality Assurance Specialist Document Control
San Diego, US
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 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.
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.
- 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.
- 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.
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