QC Analyst (Serology)

AliveDx; Penicuik; On-site; GBP 28,000 - 38,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Additional annual leave

Cycle to work

Experience days

Marketplace discounts

Job summary

AliveDx is seeking a Quality Control Analyst to join the QC Serology Department at our ARC facility near Edinburgh, EH26 0BF. You will perform quality control testing of raw materials, intermediates and final products in line with GMP, GDP and regulatory requirements to ensure accurate release to market.

The role is full-time (37.5 hours per week). You will document results, analyse data in batch records, assist training, and contribute to continuous improvement of processes in a dynamic,

Qualifications

• GMP experience in a quality control/QA laboratory environment.
• Ability to manage workload and meet deadlines with a results-driven approach.
• Experience driving continuous improvement of processes and activities.

Responsibilities

• Conduct GMP-compliant quality control testing of materials and final products.
• Analyse data and record results in batch manufacturing records.
• Prepare reports and documentation for regulatory compliance.
• Assist with staff training to support continuous capability development.
• Support safe operation and maintenance of QC equipment and processes.

Skills

GMP experience

Workload management

Continuous improvement

Under pressure performance

Lab testing

Job description

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.

AliveDx are recruiting a Quality Control Analyst to join the QC Serology Department. The purpose of the role is t o undertake the performance of quality control testing of A 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 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:

• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements.
• 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 product manufactured at Quotient (Serological, 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.

YOUR COMPETENCIES

• Laboratory experience in a GMP environment
• GMP experience
• 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
• Ability to work to under pressure

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.

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.