Quality Control Analyst (Micro)

Posted Date: 28 Jun 2024

Location: Penicuik, GB, EH26 0BF

Company: AliveDx

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

 

QUALITY CONTROL ANALYST

 

AliveDx are recruiting a Quality Control Analyst to join the Quality Control Department.  The purpose of the role is to undertake the performance of quality control testing of AliveDx’s raw materials, intermediate and final products in accordance with operational objectives, statutory and regulatory requirements, and the principles of GMP. To ensure that all AliveDx’s final products meet the appropriate specifications and regulatory requirements for release to market.   The Quality Control department is responsible for all in-process and final product testing to ensure that products manufactured by AliveDx comply with final product specifications and statutory regulations.  The department also undertakes all environmental monitoring for the manufacturing facility.

 

The role is a full-time, permanent position working 37.5 hours per week. This is to be based in our ARC facility near Edinburgh, EH26 0BF.


YOUR MISSION

Your main responsibilities will include:

 

  • Execute and control specific processes and test procedures in accordance with SOP's, GMP and Health and Safety Policies ensuring consistency and compliance with all operational policies.
  • Analyse and record data in batch manufacturing records and other relevant documentation to provide a permanent and precise record of all work carried out to ensure regulatory compliance.
  • Participate in the routine Quality Control testing of intermediate and final products manufactured at AliveDx (Serological, Biochemical or Microbiological, depending on area).
  • Preparation of reports as required.
  • Assist with the training of staff in order to ensure continuous development of staff capabilities.
  • Monitor the safe operation control and maintenance of equipment in accordance with established procedures to minimise delays to work programmes and ensure a safe working environment.
  • Participate in projects as required to ensure continuous improvement/development of products and processes.
  • Management of allocated Quality Management System records i.e. non-conformances, change controls and out of specifications.
  • Participate in an 'in-house' programme of continuous training and assessment.
  • Review and update procedures as required to ensure compliance.
  • Participate in Validation Studies as required.
  • Review of test results to ensure compliance with Specification as required.
  • Perform any other duties as reasonably requested from the Company from time to time.
  • Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements. 

 

 

YOUR COMPETENCIES

  • A relevant degree or equivalent qualification, plus relevant work experience.
  • Laboratory experience in a GMP environment
  • Experience in, biochemistry, haematology or microbiology, although desirable is not essential as training will be provided as required.
  • GMP experience.   Regular use of VDU
  • Sound knowledge and expertise with core IT packages i.e .LIMS
  • Able to manage workload with appropriate attention to getting the job done while being result orientated.
  • Continuous improvement of existing processes and activities to maximise resources.
  • Generation and implementation of novel approaches to improvement of the business

 

 

 

WHAT WE OFFER

  • A highly dynamic and growing environment.
  • An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
  • A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

 

Interested? We look forward to receiving your application.

 

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation, or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance, and business needs.