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
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
Requirements
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
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.
We look forward to reviewing your appl