Company Description
We are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.
We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.
If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our team based in Cambridge, UK!
Position
The purpose of the Quality Specialist role is to support compliance with Inivata’s Global and Local Procedures/Policies and with local regulations by applying the processes defined in Inivata’s Quality Management System. Work with the Inivata Quality team at both the UK and US facilities and work cross-functionally between teams. To assist with all areas of Quality Management including but not limited to conducting internal audits, supporting external audits, data and documentation review, maintaining records of training, acting as an archivist for the company, and preparing and revising Standard Operating Procedures.
Key Responsibilities:
Supporting activities to achieve compliance with the Inivata Quality Management System.
Promoting quality awareness and commitment to quality across the company.
Assists in administering and maintaining the electronic quality management system.
Acts as an archivist for the company and maintains physical and electronic records.
Conducts internal audits for compliance with internal SOPs and regulatory standards. Contributes to or writes audit reports.
Assists with external audit activities for regulatory agency and/or client inspections, such as participation in the preparation, gathering evidence of compliance and coordinating requests with subject matter experts. May act as a document runner and/or provide additional back room support during external audits.
Assists with gathering documentation to support laboratory credentialing, as needed.
Assists with writing, implementing, and revising QA/Quality SOPs to comply with regulatory requirements.
Coordinates review of procedures as part of the periodic review, working cross-functionally with the teams to ensure that timely reviews are completed.
In the event new or revised regulations are issued, coordinates review of changes with a cross-functional team, including Quality Assurance Management, the Laboratory Director/Management Representative, and the functional area management, as required, to determine impact and identify next steps to ensuring compliance.
Assists with review and approval of procedural deviations and change controls.
Assists in managing non-conformances and ensuring that the documentation complies with internal SOPs.
Ensure that Corrective and Preventative Actions are documented, tracked and closed within target timelines
Reviews documentation for equipment acceptance, material acceptance, batch records, and assay validations.
Assists in implementing and managing the continuous laboratory improvement program, including preparation of track and trend quality system data and key performance indicators
Assist with the development and implementation of training and education programs, to educate employees and management on quality processes, standards and results.
Maintaining training records within EQMS and MediaLab.
Having current and up to date professional knowledge, expertise and best practice.
HIPAA/GDPR Compliance: Position will
Agree to abide by Employment and Confidentiality Agreements and End User Policies
Commit to stay up to date on training requirements for HIPAA/GDPR
Understand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA/GDPR Regulations
Abide by the requirements for the proper disposal of equipment containing ePHI
Agree to report breaches and the improper handling of ePHI to the Company’s Privacy and Security Officers
Produce and adhere to proper validation documentation
Requirements
Technical Requirement:
Bachelor’s degree in biological science.
A minimum of 3 years in quality or compliance in clinical laboratory, biotechnology, GxP or regulated environment.
Industry experience in regulated Clinical/Medical Laboratories and/or IVD medical devices in the EU, UK, or US.
Skill requirement:
Ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful, and efficient, with a high level of professionalism.
Experience in Clinical/Medical Laboratory quality systems (e.g., ISO 15189, CAP (College of American Pathologists), CLIA, GCLP, HTA) or Testing Laboratory (e.g., ISO 17025) and/or IVD Medical device quality systems (e.g., ISO 13485, 21CFR820/QSR, GMP)
Prior experience of controlling QMS documents and records.
Demonstrated history of working with strong attention to detail.
Proven ability to work in a cross functional team atmosphere.
Proficient in IT (Word, Excel, PowerPoint, Outlook and Databases)
Experience working with electronic quality management systems.
Excellent written and verbal communication skills.
Proven organizational and prioritisation skills to handle multiple tasks and ability to communicate cross-functionally.
Other information
Our Values guide all our activities:
We are BOLD with the delivery of cutting edge science.
We are PASSIONATE we love what we do, our purpose and our impact on patients is clear
We are CARING we care for our patients, our partners, customers and colleagues
Inivata Limited is based in Cambridge, UK.
No agencies please.