Product Support Associate - bioLytical Laboratories Inc.

Product Support Associate
Location: Richmond, BC, Canada
Department: Product Support, Research & Development
Position: Permanent, Full-Time
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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
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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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