Quality Control Associate
Location: Richmond, BC, Canada
Department: Manufacturing, Operations
Position: Permanent, Full-Time
Did you know that you no longer have to book an appointment with your doctor and wait weeks to get lab results back for STIs like HIV and Syphilis?
bioLytical’s INSTI is the world’s fastest testing platform – providing results in just 1 minute. Yes, you read that correctly – results in 1 minute not 1 to 2 weeks! We’ve been in business since 2002 and have recently been growing like crazy with the launch of new products all over the world. bioLytical Laboratories has ranked on Business in Vancouver’s Top 100 Fastest Growing Companies list two years in a row and is the winner of the 2018 Lifesciences BC’s Growth Stage MedTech Company of the Year.
The full suite of INSTI tests are greater than 99% accurate and have a world-wide footprint of regulatory approvals including US FDA, Health Canada, World Health Organization Prequalification and CE mark for Europe. bioLytical markets its HIV point-of-care tests, HIV self-tests and dual HIV/Syphilis Multiplex point-of-care tests globally with a strong product pipeline from our research team. INSTI is the world’s fastest test, which means more people tested, more people diagnosed and more people linked to care.
We are looking for agile and energetic people to join us on our mission to end AIDS. With millions of tests already sold, INSTI is trusted by healthcare professionals and recently available to consumers. Come join us on our journey and help make a difference in the world!
As a valued member of the Quality Control team, the QC Associate plays a key role in conducting quality control activities on raw materials, subassemblies and finished goods to support Production timelines.
INSTI’S CORE VALUES:
- INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes 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 passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings and the business.
ROLE AND RESPONSIBILITIES:
- Perform incoming verification and inspection activities for raw materials against established quality specifications
- Perform inspection of INSTI components and finished devices
- Complete QC testing records and update associated tracking logs
- Maintain QC sample inventory and retention
- Coordinate 3rd party laboratory testing in accordance to the Production master schedule
- Prepare and qualify QC standards to support INSTI product testing
- Support Archived Finished Device Testing Program
- Initiate and complete Out-Of-Specification (OOS), Process Deviations Reports (PDR) and Non-Conformity Reports (NCR) related to Quality Control inspection and Testing
- Critically analyze test results and participate in investigational testing to support OOS and NCRs
- Support improvement of Product quality Key Performance Indicators (KPIs)
- Participate in investigations to support Customer Complaint Reports (CCR) and Corrective and Preventive Actions (CAPA)
- Review and revise QC documents (SOP’s, WI’s, FRM’s) as required
- Train new QC personnel on QC activities and requirements as required
The successful candidate will meet the following criteria:
- Bachelor degree or equivalent, preferably in a scientific discipline and /or relevant work experience in medical device manufacturing industry
- Minimum of two years experience in GMP manufacturing
- Knowledge of working under ISO 13485 requirements preferred
- Strong analytical skills and critical thinking
- Experience using basic laboratory equipment (balances, calipers)
- Knowledge of SDS-PAGE and Western Blot techniques
- Basic Reagent preparation experience
- Organized and detail-oriented
- Strong time-management skills, including ability to handle multiple tasks simultaneously
- Excellent computer skills (MS Office, Access, Excel)
- Excellent interpersonal skills
- Excellent written/verbal communication skills
WHAT WE OFFER:
- A competitive compensation package
- Extended health benefits including dental, optometry, RMT, etc.
- Flexible working hours
- Paid vacation
- Bonus day off WITH pay on your Birthday every year!
- Paid sick days
- Complimentary reserved parking
- Complimentary shuttle to/from the office and River Rock Hotel
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
HOW TO APPLY:
bioLytical Laboratories Inc offers a challenging, enriching work environment and competitive compensation commensurate with experience. For additional details about this opportunity and to apply, please send a cover letter and resume to firstname.lastname@example.org.
We are an equal opportunity employer and invite applications from all qualified individuals.