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!

Role Overview:

The Quality Control Specialist will play an integral part in performing Quality Control (QC) test methods and working with the clinical laboratory and clinical assay transfer teams to define specifications for purchased and in-house manufactured reagents and consumables. The high complexity nature of the work requires knowledge about reagent QC testing, analytical NextGen Sequencing methods and technology, and regulatory requirements. This role will also contribute to the development of new products, new processes, and in ensuring the consistent quality of materials used in sample testing within Inivata’s Clinical Laboratory.

This role will participate in group efforts to create and implement quality testing methods, stability data, and standard operating procedures to ensure that any quality issues with reagent or consumable lots are discovered and addressed PRIOR to their use in our Clinical Laboratory. The Quality Control Specialist will collaborate with cross-functional teams in the investigation of reagent quality issues and help drive continual improvement in efficiency and effectiveness of QC methods. (Robust System for Incoming Release of Materials).

Key Responsibilities:

• Support reagent QC testing activities for analytical NGS methods and technology
• Assist with writing and revising Quality Standard Operating Procedures to comply with regulatory requirements
• Assist with the generation of documentation for equipment acceptance, material acceptance, batch records, and assay validations
• Management of material inventory for UK laboratory
• Perform data entry into Laboratory Information Management Systems (LIMS)
• Support the qualification, preventative maintenance and calibration of instruments according to servicing schedules

• Liaise with external contractors assigned to perform servicing activities
• Collaborate with Clinical, Assay Development, Manufacturing and Quality team members
• Promote quality awareness and commitment to quality within the Clinical Laboratory
• Perform miscellaneous tasks as assigned

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

Technical Requirement:

• Bachelor’s degree in Biology, Chemistry, or related field.
• Reagent Quality Control experience is required.
• 2-4 years of relevant molecular biology experience in a laboratory setting is preferred

Skill requirement:

• Desired experience in a molecular-based clinical diagnostics laboratory managing inventory and reagent quality control processes
• An understanding of regulatory requirements for materials management
• An understanding of Quality System Regulation requirements and GMP working environment
• Familiarity or proficiency with IVD reagent manufacturing and qualification.
• Proficiency in the use of computers and Microsoft Office Applications
• Data entry experience with Laboratory Information Systems (LIS) and/or Laboratory Information Management Systems (LIMS)
• IVD experience (reagents and assays) preferred with demonstrated ability working in a team environment
• Proven organisational skills to handle multiple tasks and ability to communicate cross-functionally

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.

www.inivata.com

We look forward to reviewing your application!