Senior QA Analyst
Location: Richmond, BC
Department: Quality Assurance
Position: 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!
bioLytical’s business is expanding so we are adding top talent to support our rocketship growth and provide best-in-class engagement with our community. Reporting directly to the Quality Assurance Manager, the Senior QA analyst will be focused on providing support to evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed. You will manage the complaint investigation process end-to-end. As well as you will be participating on the ongoing QA continuous improvement project. If you are looking for a change from the ordinary and are ready to liaise with the outstanding team with greater efficiency, support, and integration then bioLytical would be the right place for you. You will play a vital role in achieving exponential growth and driving forward our mission to get people tested with the best technology on the market. You live the INSTI Core Values through and through.
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 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.
HOW YOU WILL CONTRIBUTE
- Provide quality assurance support to operations of the company, including review of batch records, release of incoming raw materials, in-process materials and finished kits.
- Provide records review and feedback to Engineering, Manufacturing related to production.
- Initiating, following up on and closing Nonconformity Reports (NCRs) and Corrective and Preventive Action Requests (CAPAs).
- Assist in the vendor monitoring and qualification processes.
- Review, revise and edit quality documents and maintain good documentation practices.
- Participate in internal and external audits.
- Performing any other QA tasks as required.
- Customer-focused, detail-oriented, team player who takes initiative and thrives in managing multiple channels and determining priorities on the fly based on urgency and time
- Evaluate, investigate, track and complete complaints through effective and established complaint handling processes as well as effectively communicate the investigations results with the customers.
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
- Participate and collaborate objectively with team members to achieve consistent processes while identifying process improvements to drive efficiency and compliance.
Coordinate with team members in obtaining any missing information.
- Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers, and Manufacturing personnel to facilitate the complaint investigation process globally.
- Review each complaint and determine eligibility for adverse event reporting to worldwide regulatory agencies if needed.
- Participate in other QA department improvement projects related to QA processes such as risk management, validation and internal audit processes
WHAT YOU WILL BRING
- Undergraduate university degree, preferably with health sciences.
- Minimum four years related work experience and a working knowledge of quality system elements.
- Knowledge of quality system regulations (ISO 13485, 21 CFR 820).
- Knowledge of medical device postmarketing regulations
- Strong process improvement and problem-solving skills.
- Knowledge or experience with cross functional areas (i.e: Production, Quality control Supply chain).
- Proficiency in common office software suites, the internet and cloud-based software applications
- Ability to work independently.
- Self-motivated, team oriented with excellent written and verbal communication skills.
WHAT WE OFFER:
- A competitive compensation package
- Dental and Extended health benefits
- Flexible working hours
- Paid vacation
- Bonus day off with pay on your birthday every year!
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- Oh and you will also have a chance to show off your dance moves and singing voice at the Christmas parties, lead in lawn bowling or volleyball at the summer barbeques and devour cake at the monthly birthday celebrations
Job Type: Full-time