Job Summary
The Quality Document Control Specialist will be responsible for the control, distribution, and administration of quality documentation that supports Technopath's quality management systems.
This role involves processing and approving document change requests, providing notifications of changes to controlled documents to relevant parties, and maintaining various logs associated with tracking of documentation or tasks.
Incoming Quality Assurance responsibilities include maintaining raw material specifications, checking raw material certificates of analysis, performing visual inspections, and reviewing batch records.
The Specialist will also support Technopath's Internal Audit program and perform other related duties as assigned by management.
Key Responsibilities
* Maintain quality documentation and ensure compliance with regulatory requirements
* Process and approve document change requests
* Provide notifications of changes to controlled documents
* Maintain various logs associated with tracking of documentation or tasks
* Support Technopath's Internal Audit program
* Perform incoming quality assurance activities, including raw material specification maintenance, certificate checks, visual inspections, and batch record reviews
Qualifications
* Minimum of a degree qualification in a relevant Science, Engineering, or QA subject area
* 2+ years of industry experience working in a regulated environment for medical devices
* BASIC knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746, and international regulatory requirements
* Excellent communication skills and attention to detail
Our Values
* PASSION: We are driven by our passion for delivering high-quality results
* CURIOSITY: We encourage curiosity and a willingness to learn
* INTEGRITY: We operate with integrity and honesty in all aspects of our work
* BRILLIANCE: We strive for brilliance in everything we do
* RESPECT: We treat each other with respect and dignity
Benefits
* 25 days of holiday leave per year
* Life assurance and health allowance
* Discounts with local and national retailers
* Free 24/7 Employee Assistance Programme
* Recognition schemes and monetary awards
We foster a culture of inclusion and collaboration at LGC. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities.