Product Support Associate Location: Richmond, BC, Canada Department: Product Support, Research & Development Position: Permanent, Full-Time ______________________________________________________________________________ ABOUT BIOLYTICAL bioLytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002 and focused on the research, development and commercialization of rapid, point-of-care in vitro medical diagnostics developed using its proprietary INSTI™ technology platform. Today, the company sells and markets its INSTI™ HIV test and has a world-wide footprint of regulatory approvals including US FDA approval, Health Canada approval and CE mark. Our product provides a highly accurate HIV test result in as little as 60 seconds which translates into a compelling value proposition for patients, healthcare professionals, and public health organizations. SUMMARY As a member of the Product Support team, within the Research & Development department, the Product Support Associate is responsible for providing laboratory support for products that are fully commercialized and being sold in either USA, Canada, Europe or the Rest of World. This position reports to the Team Lead, Product Support. Phase 0 Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 Initial Evaluation Concept/Feasibility Project Planning & Initial Design Design Verification Design Validation Design Transfer Product Launch & Post Launch Assessment Post Market Surveillance Discovery Research Discovery Research Product Development Product Development Product Development Product Development Product Support Product Support ROLE AND RESPONSIBILITIES Manage all stability studies initiated during design and development and initiate accelerated and real time studies to support product and design changes Investigate, trouble shoot and resolve customer complaints Investigate nonconformities and provide recommendations for material disposition and corrective actions Investigate and perform root cause analysis for corrective actions Participate in developing and executing process validations protocols Plan, design and execute new and modified in vitro diagnostic device design projects, as directed by the Team Lead, Product Support or Director, R&D Conduct laboratory examinations, immunoassays and investigational determinations on blood and blood products for product improvements Accurately read, interpret and record the results of laboratory tests Provide technical and complex information clearly to research personnel as well as to members of other departments including Manufacturing, Quality Assurance and Sales & Marketing Assist in research, planning and evaluation of alternate methods and testing procedures Assist with training of laboratory or other related personnel QUALIFICATIONS The successful candidate will meet the following criteria: Bachelor degree in a life sciences discipline, preferably in medical technology, microbiology, biochemistry, chemistry, biology or related science. Minimum 2 years’ experience in a research or clinical laboratory Knowledge of and direct experience with ISO 13485 Knowledge of or experience with GLP, GMP work desired Excellent interpersonal skills, oral communication skills, and written communication skills are required Must be able to work independently following a brief period of specific technical training Must have strong analytical and technical writing skills Excellent computer skills (MS Office, Access, Excel) Organized and detail-oriented HOW TO APPLY BioLytical Laboratories Inc. offers a challenging, enriching work environment. To apply for this opportunity, please send your resume and current salary to [email protected] We are an equal opportunity employer and invite applications from all qualified individuals.
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