Lisa Hellier, Cqp Mcqi Email & Phone Number

Hinxton, England, United Kingdom

Supporting Cellular Operations and the Genomic Surveillance Laboratory Platform on their Quality Management journey. Focused on embedding a culture of quality and compliance through the successful implementation of the Scientific Operations Quality Policy and the introduction of a formal Quality Management System (QMS).Key achievements include:- Providing strategic leadership in the development and execution of lasting quality processes that drive continuous improvement and robust change control.- Implementing a quality framework to ensure alignment with regulatory standards and operational efficiency.- Developing Training and coaching teams on quality principles and best practices to ensure successful adoption of new systems.- Collaborating with cross-functional teams to integrate quality measures into daily operations, fostering a proactive quality culture.

London, United Kingdom

• Achieved acccreditation to ISO 9001:2015 over a year ahead of schedule. • CAPA and investigation lead.• Introduction of Quality training units for all staff to improve documentation practice and compliance.• Complaint and internal audit management to ISO 9001.• Ensuring compliance with ICH-GCP and update to ISO 9001:2015 standards.• Coordination of external assessments by sponsors and agencies such as the MHRA.• Computer Systems validation of CAPA management software.• Responsible person for first aid, health and safety on site. Received commendation from the H&S management company for compliance with UK legislation.

Dartford, United Kingdom

Leading a team of 12 technicians and manage the manufacture of antibodies and antigens using mammalian cell culture techniques. Focus on resource management, quality, compliance and process improvement. Facilitating the introduction of new processes and design changes into routine manufacturing.Control of environmental parameters (i.e. microbial load in water and on surfaces) and trend analysis.

Dartford

Working in the Quality Assurance department my responsibilities included incoming raw material approval, final product sign-off, internal and external audit support (FDA, TUV), documentation updates and new product release.

Dartford, United Kingdom

Assisting in the transfer of diagnostic products from the US to the UK. Highlighting potential problems, assessing and proofreading manufacturing paperwork. Processes to review are fermentation, purification and QC testing.

Developing immunodiagnostic kits including latex agglutination and ELISAs as a part of the R&D team.Greatest success: Taking on sole responsibility for the final phase of product development. The product launch of the first new kit developed on site, a latex agglutination assay for the identification of Streptococci.Additional roles: Head of the Social Committee, elected to represent the site in the UK and Europe in a Communications forum set-up to improve inter-company relations, trained First Aider.Main skills gained and responsibilities:Organising own work efficiently and meeting project deadlinesDevelopment of latex agglutination assays for the identification of Streptococci and StaphylococciAntibody purificationProcess verification and validationCreating training modules, Standard Operation Procedures and production paperwork.Taking responsibility for staff training on production processes and organise product scale-up.Connecting departments to allow smooth launch and effective processes

Manufacture and Quality Control of immunodiagnostic kits (ELISA, Immunofluorescence tests) and molecular kits (PNA, FISH). I joined the company on a temporary contract to gain work experience during the summer break of my university course. During that time a position as a manufacturing technician became available and I decided to permanently move to England and transfer to a part-time university course in order to take the position.Greatest success: Receiving a financial bonus under the ThermoFisher Scientific employee reward scheme in recognition of my performance. Additional roles: Member of the Social Committee, Fire Safety OfficerMain skills gained and responsibilities: Taking responsibility for manufacture of molecular OEM customer products (AdvanDx PNA and FISH)Responsible for accurate documentation and complying with ISO 9001 and ISO 13485 standards and improving documentation accordingly

Proof reading of both German and English press releases. Alone responsible for organising and filing articles and advertisements relating to two major museums in Vienna (Mozart House, Jewish Museum), showing attention to detail and handle documentation in a neat manner.

Vienna, Austria

Translation of English and German scientific texts including Information for Use leaflets and risk assessment certificates for immunodiagnostic products.

Msc, Medical Diagnostics, 70% Average

Activities and Societies: MSc Medical Diagnostics expected finish: Sept 2012 Cranfield University, Cranfield Part-time course.

Bsc (Hons), Microbiology, 2.1

Activities and Societies: Volleyball teamPart-time course while working full-time. Modules such as Laboratory Techniques for Biomedical.

Food Science And Biotechnology

Education record