Quality Assurance Associate

6 months ago

Vancouver, Canada Cytiva Full time

**Be part of something altogether life-changing**

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 that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Cytiva QA Associate is responsible for managing controlled documentation and training programs in accordance with GMP, ISO 9001, and corporate requirements.

This position is part of the QMS team in Vancouver, BC- Canada, and will be hybrid. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.

**What you will do**:

- Utilize the Veeva document management system (eDMS) to facilitate document control activities, including developing and managing policies, procedures, work instructions, forms, templates, job aids, and other quality documents, ensuring compliance with regulatory requirements and company standards throughout the review, approval, distribution, and archival processes. Additionally, participate in internal/external audits and continuous improvement initiatives to enhance document control and training processes.
- Collaborate with cross-functional teams to address document-related issues and facilitate timely revisions and periodic reviews as needed.
- Coordinate the training program for new hires and existing employees using the Cornerstone Learning Management System (LMS), including scheduling training sessions, preparing reports, and tracking completion. Collaborate with departmental managers to identify training needs, develop training plans, and maintain the site's training matrix.
- Assist in developing and implementing quality system procedures to maintain compliance with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
- Issue and reconcile batch records, logbooks, and other controlled documentation, including organizing documentation physically as needed.

**Who you are**:

- Post-secondary education in a scientific or technical field.
- 3+ years of industry experience in document management and/or training in a GMP pharmaceutical, biologic manufacturing, or ISO 9001:2015 certified environment.
- Comfortable with the ability to work independently and collaboratively to manage work efficiently.
- Passionately detail-oriented with a commitment to quality excellence.

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

- Electronic Document Management Systems (eDMS) and Learning Management Systems (eLMS) such as Veeva QualityDocs and Cornerstone OnDemand.

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Your interview team will provide additional information about this hybrid work arrangement. Explore the flexibility and challenge that working for Cytiva can provide.

The salary range for this role is CAD $70,000 - $85,000 CAD_._ This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and retirement planning benefits to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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