JOB VACANCY: WE NEED A Quality Control leader WITHIN OUR OPERATIONS TEAM 

genedrive plc is an AIM listed diagnostic company.  The company was formed in 2007 and is based in Manchester.  The company’s origins are in preclinical research, however the focus of the company is now on the development and commercialisation of our Genedrive® system.

Genedrive®, is an affordable, end-point PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens, such as TB or Hepatitis. As we further develop our Point of Care philosophy through product development and refinement, we have an opportunity to reach millions of people with poor access to existing diagnostic technology. Ultimately, Genedrive has the ability to change lives through rapid access to the benefits of molecular diagnostics.

With the continuing growth of the company, a need has been identified for this pivotal role in the smooth transfer of products from R&D into Manufacturing and then to our Customers, taking place within a Quality Management System supporting IVD regulatory global compliance.

ROLE SUMMARY

We are looking for a QC Leader to join our Operations Team, within our Diagnostics Division. You will play a key supporting role across various areas of the business providing strategic direction & expertise on quality issues in manufacturing in relation to in-process QC testing, coordination with R&D for the adoption of QC methods for new and incoming products and post – sale vigilance. You will be expected to plan the workload, lead and train a small team whilst also working at the laboratory bench when required.

The ideal candidate will have strong practical experience in molecular diagnostic reagent and consumable QC in order enhance and further embed QC within Operations – at a crucial time in the lifecycle of our product. You will lead our QC function so that our Operations Team can consistently meet and exceed the challenges of producing units for point of sale /distribution.  There will be the opportunity to contribute to the strategy and future planning of the Operations Team with in-post experience.   

THE ROLE

You will report to the Operations Manager and, as the QC Leader, you will undertake the following duties:

  • To act as the Subject Matter Expert in relation to QC processes in relation to regulatory and client audits
  • Incoming component & product sub-assembly release control.
  • QC of lifecycle of materials - supporting component and product stability studies
  • In-process QC testing and release plus post-sale vigilance
  • Undertake trend analysis of data - tracking & deviation identification
  • Support company-wide technical development and manufacturing projects as required
  • Collaborate and maintain strong leadership links with IVD Project Teams to ensure productive and regulatory compliant development and design for manufacture
  • Represent the Operations Team on cross-functional product teams by taking responsibility for QC activities to support R&D and Regulatory submissions
  • Liaise as necessary with our company-wide Quality Assurance and Regulatory colleagues & management
  • Leadership of Operations Technicians when assembled as a QC team to fulfil the process requirements of the business
  • Membership of the wider Operations Team with responsibilities to support, training, task planning and resource allocations

WHAT SORT   OF PERSON ARE WE LOOKING FOR?

YOUR EXPERIENCE

& KNOWLEDGE

Experience of leading a team and working safely in a laboratory environment.

You will have experience of working in a regulated product manufacturing environment. We work to ISO 13485 –Medical Devices and Good Laboratory Standards (GLS).

Experience of Quality Control processes in IVD development

You understand and are comfortable with the mathematics and statistics of quality control in in vitro diagnostics.

Experience of working to Standard Operating Procedures (SOP’s).

You will have experience of writing Standard Operating Procedures (SOPs) and working to them on a daily basis.

Practical laboratory experience with molecular diagnostic (PCR) reagents and products

You are proficient in real-time PCR techniques and data interpretation. Proficient in maintaining clean PCR working practices and workflow containment.

Maintaining and operating laboratory equipment.

You are fully competent using computers with standard Office software.

YOUR QUALIFICATIONS

& TRAINING

A science graduate, potentially with post-graduate qualification in a relevant discipline.

You will have experience in industry or health service laboratories with evidence of leadership.

YOUR CAPABILITIES

You will be an influencer with good spoken and written communication skills.

You will be able to communicate with colleagues across the business and with our clients and suppliers. You will have the gravitas to develop and drive QC activities within Operations.

You will be able to perform routine testing in order to produce reliable and precise data

You will have experience in interpreting results and reporting on them. You will be comfortable with the trend analysis of data.

You will have an organised and methodical approach to all work activities.

You will be able to comfortably prioritise workloads based on business needs.

 

You will be a confident problem-solver and decision maker.

You will be comfortable leading ‘root cause’ analysis and providing solutions.

 

WHERE WILL I BE WORKING?

You will be based at our offices within the University of Manchester Innovation Centre, on Grafton Street, off Oxford Road and situated close by the entrance to the Manchester Royal Infirmary in Central Manchester.

WHAT WILL BE MY SALARY BE?

We are offering a competitive salary.

HOURS OF WORK

You will be required to work 37.5 hours per week between the hours of 8 am and 6.00pm. You can discuss your ideal start and finish time with us.

COMPANY BENEFITS        

We provide a Private health care scheme,

Group income protection and a Share purchase option scheme, 25 days holiday per year,

together with a Group Personal Pension scheme.

I AM INTERESTED IN APPLYING FOR THE ROLE   ?

If you are interested in applying for the role of QC Leader please send in your CV and covering letter to us via our email at:  Careers@genedrive.com

Please focus on telling us on how your skills and experience match the type of person we are looking for and why you think you would be an ideal candidate to undertake the role of QUALITY CONTROL LEADER

DEADLINE FOR CV’s & COVERING LETTER

Please get your CV and covering letter over to us no later than 5.00pm on Friday 1st December 2017.

We look forward to hearing from you!

No agencies please.

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