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Bioline
,
London, Greater London
Quality control development Manager
Overview
Job Description
Job Summary Bioline develops, manufactures and markets a wide range of specialized bio-research reagents that simplify, accelerate and improve life sciences research. The successful candidate will work as part of the QA/RA team in the area of quality control to promote product quality and consistency by improving analytical methods and by supporting the introduction of new assays for Bioline's growing product portfolio. This role will help to ensure that Bioline meets the standards and expectations of customers, key stakeholders and potential collaborators. Main task of the position is optimisation and validation of quality control assays but the role will involve also the running of routine, molecular biology based assays, support of transfer and validation of new assays, examination/assessment of product stability and undertaking projects in conjunction with other departments, in the first instance R&D and operations. The role is laboratory based with significant amount of paperwork. Key Duties Analyzation, review and optimization / redevelopment of quality control assays for legacy products including generation of required documentation. Planning, production of documents for and overseeing performance of legacy product assay validation. Supporting validation of quality control assay of new products Participation in long term stability program Providing input to and participation in analytical assay troubleshooting investigation Participation in routine Quality Control tasks including preparation of QC reports and other documents related to products quality control. Assuring that all documents required by Bioline's QM System related to assay development and validation are prepared in a timely manner in accordance with agreed priorities and plans. Supporting QC and R&D staff member during generation of required documentation and when required review of the same. Support R&D as part of project teams to deliver new or revised product to the market Assisting in the investigation and completion of Non-Conformance reports and CAPA improvements. Knowledge, Skills and Abilities: Very good understanding and background of real-time and endpoint PCR Profound knowledge of analytical methods related to molecular biology products and practical experience of the same. Excellent experience of general molecular biology techniques Understanding of common statistical analysis Knowledge of regulatory standards like ISO 13485 would be an advantage Excellent organizational skills with a methodical approach to work and attention to detail. Must be able to prioritize, organize workloads and meet task deadlines. Dedicated, flexible personality who is able to work independently and, in a team, Ability to interact effectively with an interdisciplinary group on various levels. Excellent communication skills and good knowledge of written and spoken English. Qualifications MSc, PhD or equivalent in life science 3 years of experience or equivalent preferable in relevant industry