Quality Assurance Specialist

Vanrx Pharmasystems; Burnaby; On-site; CAD 79,000 - 90,000; Full time

Job summary

A life sciences company in Burnaby is looking for a Quality Assurance Specialist to lead the Complaint Handling Unit. You will support investigations, audits, and ensure compliance with quality standards. Candidates with a Bachelor's degree in Biological Sciences or similar, and relevant experience are preferred. The salary range is $79,500-$90,000 CAD, with additional benefits including paid time off and health insurance.

Benefits

Comprehensive healthcare benefits

Paid time off

Bonus/incentive pay

Qualifications

• Multiple years of experience dealing with post-market surveillance activities.
• Experience working with cross-functional teams.
• Excellent verbal, written, and presentation skills.

Responsibilities

• Lead a Complaint Handling Unit and execute triage, investigation, and closure of product quality complaints.
• Facilitate risk assessment activities.
• Support internal and external audits as a Subject Matter Expert.

Skills

Verbal communication

Written communication

Problem-solving

Statistical analysis

Education

Bachelor's degree in Biological Sciences or related field

Tools

Veeva

TrackWise

Salesforce

Magic

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within the fields of life sciences diagnostics and biotechnology?

At Cytiva, one of Danaher's 15 operating companies, our work saves lives, and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher's system of continuous improvement, you help turn ideas into impact, innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva, you will be able to continuously improve yourself and us, working on challenges that truly matter with people who care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System, which makes everything possible.

The Quality Assurance Specialist is responsible for leading a Complaint Handling Unit (CHU), supporting and executing triage, investigation, and closure of product quality complaints. Additional key responsibilities include metrics follow-up and analysis for items in the CAPA and nonconformity system, whether or not complaint-related.

This position reports to the Senior QA Manager and is part of the Quality Assurance team located in Burnaby, BC. It will be an on-site role.

What you will do :

• Lead a Complaint Handling Unit (CHU), supporting and executing triage, investigation, and closure of product quality complaints. Tasks include coordinating investigations, running trend reports, performing statistical analysis of trends, tracking major issues and related corrective actions, assisting in final customer reports, and interfacing with customers in various forms of communication.
• Facilitate risk assessment activities and act as QA lead for Field Actions involving Aseptic Filling product groups.
• Support internal and external audits as Subject Matter Expert from a complaint handling unit perspective.
• Provide metrics and oversight of the deviation, CAPA, and complaint systems, including high-level analysis for management review.

Who you are :

• Bachelor's degree in Biological Sciences, Engineering, or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry) or equivalent work experience.
• Multiple years of relevant experience dealing with post-market surveillance activities (complaint triage, investigations, CAPA, etc.).
• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English.
• Experience working with cross-functional teams and facilitating solutions to complex problems.
• Experience with root cause analysis, nonconformance investigation, and CAPA management.

It would be a plus if you also possess previous experience in :

• Experience in regulated environments such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
• Proficiency with quality management systems (QMS) and tools like Veeva, TrackWise, Salesforce, Magic.

Cytiva, a Danaher operating company, offers comprehensive competitive benefits programs that add value to our lives. Whether it's healthcare or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The salary range for this role is $79,500-$90,000 CAD. This range reflects the current estimate of possible compensation at the time of posting and may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance for eligible employees.

Note : No amount of pay is considered wages or compensation until earned, vested, and determinable. The amount and availability of bonuses, commissions, benefits, or other compensation remain at the company's sole discretion unless paid, and may be modified at the company's sole discretion, consistent with law.

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Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers worldwide to help solve complex challenges, architecting solutions that bring the power of science to life.

For more information, visit our website.

Danaher Corporation and all Danaher companies are committed to equal opportunity employment regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We ensure individuals with disabilities are provided reasonable accommodations to access our website and participate in the application or interview process, perform job functions, and receive employment benefits. Please contact us at 1- or to request accommodation.

Required Experience :

Unclear Seniority

Key Skills

Invoicing, Information Technology Sales, IT Support, Audio Visual, Database Administration

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary : 79,500 - 90,000 CAD