QA Specialist

5 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 Quality Assurance Specialist for Cytiva is responsible for providing technical expertise and guidance for all activities associated with Microbiology, Sterilization, and Aseptic programs to support Manufacturing, Environmental Monitoring, QC Microbiology, and site projects related to GMP pharmaceutical operations. This will include cross-functional collaboration with groups such as Biomanufacturing, Quality Control,QC Microbiology, Facilities, Quality Assurance, and 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**:

- Develop, implement, and coordinate the site sterility assurance and related programs through support and collaboration with all stakeholders.
- Review/approve assessments, procedures, technical reports, and other sources of information to ensure that microbiological sampling and testing methods are consistent with compendial guidance, current industry practices, and regulatory requirements.
- Provide technical expertise and is responsible for ensuring the design of microbiology and sterilization validation (aseptic process validation) studies will meet requirements.
- Review investigations related to environmental monitoring or microbiological testing of raw materials, components, excipients, bulk substances and finished goods and review environmental, utility, and microbial trend reports, and recommend corrective and preventive actions.
- Evaluate and enhance current programs to improve compliance, efficiency, and effectiveness leading to customer retention and an overall organizational culture of Quality.

**Who you are**:

- Undergraduate education in Microbiology, Biochemistry, or related science with significant microbial coursework.
- Long-standing experience in a pharmaceutical, biotech or medical device environment, preferably supporting a GMP cleanroom environment.
- Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin levels, biological indicators, cleanroom contamination, environmental monitoring, aseptic process simulations, gowning, and cleaning/disinfection.
- Demonstrated industry experience in several of the following areas: microbiological method development and validation, container-closure integrity testing (CCI), microbial ingress, process hold time studies, aseptic process simulations, WFI generation system validation and routine monitoring requirements, equipment cleaning verification and/or validation, vaporized hydrogen peroxide validation approaches.
- A solid understanding of applicable regulations and guidelines as well as experience with GMPs for Clinical Trial Materials in a working manufacturing environment.

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

- Influencing and coaching others. Able to demonstrate and teach not just the how, but the why and develop a culture where everyone owns Quality.

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 a comprehensive package of benefits including paid time off, medical/dental/vision insurance and retirement plans to eligible

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