- Develop and implement a holistic GMP materials management compliance program with other key stakeholders scoped from material identification and onboarding assessment to material disposition and use in clinical GMP manufacturing.
- Participate in and contribute to material assessments for potential incoming goods to determine suitability for intended use e.g., compliance with EMA 410/01, susceptibility for melamine contamination, excipient requirements (IPEC guidelines), plastics/glass requirements, sterility assurance requirements, etc. as part of the material onboarding process.
- Review/approve assessments, procedures, technical reports, material specifications and other sources of information to ensure that the material management program and materials themselves are consistent with compendial guidance, current industry practices, and regulatory requirements.
- Review and approve investigations related to inspection and/or testing of incoming goods such as raw materials, components/consumables, excipients, labeling, and packaging materials.
- Perform material disposition activities including inspection of components, review of documentation and raw data, and updating statuses in the ERP system.
- Undergraduate education in Biological Sciences, or related science
- 7 - 10 years of experience in a pharmaceutical or biotech environment, preferably supporting a GMP cleanroom environment
- Demonstrated industry experience in raw material, consumable, and excipient onboarding assessments for the suitability of use in pharmaceutical manufacturing
- A solid understanding of applicable regulations and guidelines as well as experience with GMPs for Clinical Trial Materials in a working manufacturing environment.
- Influencing and coaching others. Able to demonstrate and teach not just the how, but the why and develop a culture where everyone owns Quality.
- Communicating with vendors with respect to outlining quality requirements and negotiating corrective actions in response to nonconformances.
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QA Specialist - Vancouver, Canada - Danaher
Description
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 Quality Assurance Specialist is responsible for leading QA initiatives and supporting operational programs for raw materials, consumables, warehousing, and supply chain programs. The QA Specialist provides oversight and guidance for materials managementand supply chain programs to support the company's GMP clinical manufacturing, testing, and warehousing facilities. This is a highly collaborative position that will involve liaising with groups such as Process Development, Manufacturing, Quality Control, Supplier Quality, Sourcing, Procurement, and Warehousing as well as external customers.
This position is part of the Quality Assurance department located in Vancouver, BC, Canada and will be hybrid, eventually transitioning to on-site. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
What you'll do:
Who you are:
It would be a plus if you also possess previous experience in:
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. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.
The salary range for this role is $74,500 - $130,500 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 plans 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.
#LI-LW1
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
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.
