Laboratory Specialist, Quality Assurance

JenaValve is a privately owned medical device company focused on the design and manufacture of Pericardial Transcatheter Aortic Valve Replacement (TAVR) Systems, intended to treat patients with Symptomatic, Severe Aortic Regurgitation and Stenosis.

Our production site in Leeds, manufactures the proprietary porcine pericardial heart valve used in the JenaValve Pericardial TAVR System.

We are looking to recruit a Laboratory Specialist to provide quality assurance support the Leeds Laboratories (chemistry and microbiology). The role will involve supporting the QA team to ensures site is compliant with company and regulatory requirements for:

• Biocontamination control / monitoring program per ISO 14698, other relevant standards, and internal procedure.
• Manufactured solution analysis / release for production use.
• Laboratory method development, qualification, transfer, and analyst training / certification.
• Laboratory equipment calibration, maintenance, and qualification.
• Conduct of solution shelf life/stability studies (including protocol, report development).
• TLS sterilization activities and annual review/ revalidation(s). 
• Packaging component sterilization (steam and gamma irradiation) and process oversight
• Contract laboratory finished product endotoxin and testing.
• Data governance/review and data integrity requirements (good documentation practice).
• Identifying and supporting continuous improvement initiatives in laboratory documentation and practices.
• Providing ongoing visibility of laboratory activities, deviations, and projects to supervisor/QA team. 

Supports site Operations and Quality Assurance in executing laboratory workloads per assigned priority while assuring compliance with applicable procedures, standards, and regulatory requirements, encompassing:

• Routine solution analysis (chemical, microbiological) and release to production.
• Ongoing environmental monitoring and controlled environment certification(s).
• Training other Leeds personnel involved in laboratory testing.
• Ensuring data is documented per procedures and regulatory requirements and is reported to supervisor/Quality management in a timely manner. Supporting development of monthly trend analyses as required.
• Supporting preparation of protocols, protocol execution, and report preparation for validations; assures compliance with the site Validation Master Plan.
• Supporting continuous improvement initiatives for efficiency and productivity in relation to lab practices, site biocontamination control program, work instructions/forms, and site support activities.
• Providing technical support/ troubleshooting in the event of lab equipment failure, deviations or out of specification results. Participates in and documents root cause analysis investigations and assists in the development and implementation of corrective and/or preventive actions.
• Supporting site Health and Safety program (COSHH) and assists in Risk Assessments as assigned.
• Represents Chemistry and/or Microbiology laboratories on cross-functional teams as assigned.
• Ensuring company and regulatory requirements are met for laboratory personnel training, lab records/ documentation, and overall lab record retention requirements.
• Other responsibilities as assigned by management.

• Bachelor of Science degree or equivalent, in a division of Chemistry, Biology, Biochemistry, Microbiology, or Biomedical-related discipline.
• Basic knowledge of cGMP, Quality System, and risk management principles (21CFR820, ISO 13485, ISO 14698, ISO 14971.

• Able to prepare documented investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Able to interpret complex results and situations with support and recognize patterns and trends in reported data. Able to effectively articulate recommendations for solutions (verbally and in writing) cross-functionally and negotiate to completion. Recognizes risk and develops contingency plans.
• Self-motivated, action-oriented, customer-focused, and skilled in building relationships, problem solving, conflict management, planning/organizing, mentoring, and analytical thinking.
• Prepares written communications with clarity and accuracy.
• Works with minimal supervision; consults management for advice on issues as needed.

Salary: £30,000 per year

Benefits:

• Company pension
• Free parking
• AXA Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus