Associate II, Quality Assurance
Top Benefits
About the role
Reporting directly to the Quality Assurance Manager, the Associate II, Quality Assurance, is responsible for providing support to Quality Assurance daily activities. You will contribute to CAPAs, supplier monitoring, and validations—ensuring consistent, reliable, and high-quality medical devices exit the facility. This position requires a strong attention to details, report writing proficiency, and cross-functional collaboration, with opportunities to shape groundbreaking diagnostic technologies that impact global healthcare.
If this sounds like the position you are looking for, apply today!
ABOUT BIOLYTICAL
bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail’s Fastest Growing Companies list in 2020. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have been featured on BC’s Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.
HOW YOU WILL CONTRIBUTE
-
Reviewing and approving vendor proofs for labelling artwork.
-
Assist with Change Control and Document Control activities as required.
-
Organize and file Quality related records; Archiving and indexing of QMS documents.
-
Performing QA review of records for release of incoming raw materials, records related in-process materials and finished batch records.
-
Review, revise, and edit quality documents.
-
Perform Supplier Monitoring and Qualification.
-
Initiating, following up and closing Supplier Corrective Action Reports (SCAR’s).
-
Conducting QA review and approving Process Deviation Reports (PDR’s). · Initiating, following up, closing and performing effectiveness check of Corrective Action and Prevention Actions (CAPA).
-
Assisting in initiating, investigating and closing Non-Conformity Reports (NCR’s) as required.
-
Assist with risk management activities; reviewing FMEA & pFMEAs.
-
Review Validation, Stability Study and Internal Study protocols and Reports
-
Participate in management review, internal and external audits as needed. · Perform data analysis in relation to QMS records.
-
Performing any other QA tasks as required.
WHAT YOU BRING
-
Undergraduate university degree, preferably in a scientific discipline.
-
Minimum 3 years experience in a quality related position, preferably in medical device -IVD.
-
Preferable 2 years working experience with Medical Device Quality System regulations.
-
Proficiency in common office software suites, the internet, and cloud-based software applications.
-
Ability to work independently.
-
Ability to travel for potential on-site supplier audit as required.
-
Self-motivated, team oriented with excellent written and verbal communication skills.
WHAT WE OFFER
- A competitive compensation package
- Extended health benefits including dental - 100% employer contribution
- Flexible working hours
- Paid sick days
- Bonus day off with pay on your birthday every year!
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
- The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table
The annual base salary for this job ranges from:
$58,000-$63,000
bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.
CORE VALUES
INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
NEVER SAY NEVER : Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
#manufacturing #lifesciences #diagnostics #medicaldevice #validation #qualityassurance #qms
About bioLytical
Biolytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002. Our mission is to improve the quality of people’s lives by providing innovative solutions for infectious disease diagnosis, the first step in the linkage of patients to appropriate care and treatment. Today, the company sells and markets its INSTI™ HIV test supported by worldwide regulatory approvals including US FDA approval, Health Canada approval and CE mark in Europe.
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, payers and public health organizations. We have an active R&D program and our pipeline includes INSTI™ tests for diseases such as Hepatitis C and Syphilis. The company also provides contract services to adapt the INSTI™ platform to meet custom functional and technical diagnostic testing requirements. Our vision is to be a global leader in the research, development and commercialization of rapid, point-of-care in vitro medical diagnostic devices.
Associate II, Quality Assurance
Top Benefits
About the role
Reporting directly to the Quality Assurance Manager, the Associate II, Quality Assurance, is responsible for providing support to Quality Assurance daily activities. You will contribute to CAPAs, supplier monitoring, and validations—ensuring consistent, reliable, and high-quality medical devices exit the facility. This position requires a strong attention to details, report writing proficiency, and cross-functional collaboration, with opportunities to shape groundbreaking diagnostic technologies that impact global healthcare.
If this sounds like the position you are looking for, apply today!
ABOUT BIOLYTICAL
bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail’s Fastest Growing Companies list in 2020. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have been featured on BC’s Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.
HOW YOU WILL CONTRIBUTE
-
Reviewing and approving vendor proofs for labelling artwork.
-
Assist with Change Control and Document Control activities as required.
-
Organize and file Quality related records; Archiving and indexing of QMS documents.
-
Performing QA review of records for release of incoming raw materials, records related in-process materials and finished batch records.
-
Review, revise, and edit quality documents.
-
Perform Supplier Monitoring and Qualification.
-
Initiating, following up and closing Supplier Corrective Action Reports (SCAR’s).
-
Conducting QA review and approving Process Deviation Reports (PDR’s). · Initiating, following up, closing and performing effectiveness check of Corrective Action and Prevention Actions (CAPA).
-
Assisting in initiating, investigating and closing Non-Conformity Reports (NCR’s) as required.
-
Assist with risk management activities; reviewing FMEA & pFMEAs.
-
Review Validation, Stability Study and Internal Study protocols and Reports
-
Participate in management review, internal and external audits as needed. · Perform data analysis in relation to QMS records.
-
Performing any other QA tasks as required.
WHAT YOU BRING
-
Undergraduate university degree, preferably in a scientific discipline.
-
Minimum 3 years experience in a quality related position, preferably in medical device -IVD.
-
Preferable 2 years working experience with Medical Device Quality System regulations.
-
Proficiency in common office software suites, the internet, and cloud-based software applications.
-
Ability to work independently.
-
Ability to travel for potential on-site supplier audit as required.
-
Self-motivated, team oriented with excellent written and verbal communication skills.
WHAT WE OFFER
- A competitive compensation package
- Extended health benefits including dental - 100% employer contribution
- Flexible working hours
- Paid sick days
- Bonus day off with pay on your birthday every year!
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
- The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table
The annual base salary for this job ranges from:
$58,000-$63,000
bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.
CORE VALUES
INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
NEVER SAY NEVER : Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
#manufacturing #lifesciences #diagnostics #medicaldevice #validation #qualityassurance #qms
About bioLytical
Biolytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002. Our mission is to improve the quality of people’s lives by providing innovative solutions for infectious disease diagnosis, the first step in the linkage of patients to appropriate care and treatment. Today, the company sells and markets its INSTI™ HIV test supported by worldwide regulatory approvals including US FDA approval, Health Canada approval and CE mark in Europe.
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, payers and public health organizations. We have an active R&D program and our pipeline includes INSTI™ tests for diseases such as Hepatitis C and Syphilis. The company also provides contract services to adapt the INSTI™ platform to meet custom functional and technical diagnostic testing requirements. Our vision is to be a global leader in the research, development and commercialization of rapid, point-of-care in vitro medical diagnostic devices.