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QA Associate
2 weeks ago
Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry 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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The CQV Associate is responsible for supporting the commissioning, qualification and validation (CQV) program for equipment, utilities, facilities, and computerized systems. You will get to provide oversight and guidance for all CQV activities that support our company’s GMP clinical manufacturing and testing facilities. This is a highly collaborative position that will involve liaising with groups such as Process Development, Manufacturing, Quality Control, Facilities, Information Technology, and Quality Assurance.
**What you'll do**:
- Review and approve validation lifecycle documentation (e.g., URS, DQ, FAT, SAT, IQ, OQ, PQ, protocols and reports) to ensure a compliant initial qualification/validation, and that a qualified/validated state is subsequently maintained.
- Perform validation risk assessments, Part 11/Annex 11 assessments, and data integrity evaluations in support of validation lifecycle management.
- Ensure execution of validation and qualification deliverables according to Validation Project Plans and/or Master Schedules and report on metrics to key stakeholders.
- Review and approve deviations, investigations, change controls, and CAPAs related to qualified/validated systems, equipment, and facilities.
- Support the development and implementation of a risk-based lifecycle approach for validation in a GMP environment per industry regulations, guidance, and best practices (such as GAMP).
- Represent QA on e-system implementations across the site, considering the operational, compliance, and qualification needs of the organization.
- Support the development of the Site Master Validation Plan and ensure its ongoing maintenance.
- Contribute to the development and maintenance of training programs to promote validation best practices (e.g. requirements in validation, maintenance, and use of computerized systems)
- Maintain qualification/validation documentation and coordinate onsite archival to ensure efficient document retrieval.
- Support the evaluation and enhancement of current programs to improve GMP compliance, efficiency, and effectiveness leading to customer retention and overall organizational culture of Quality.
**Who you are**:
- Undergraduate education in Biological Sciences, Engineering, or related science.
- Several years experience in a pharmaceutical, biotech or medical device environment required, preferably supporting a GMP cleanroom environment.
- Strong technical expertise in areas related to GMP equipment, cleanrooms, critical utilities, computerized systems, aseptic process simulations, and data integrity requirements.
- Demonstrated experience with global cGMP requirements and other applicable regulations/guidelines pertaining to equipment qualification and validation of computerized systems.
- Strong desire to influence and coach. Able to demonstrate and teach not just the how, but the why and develop a culture where everyone owns Quality.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.
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.
If you’ve ever wondered what’s within you, there’s no better time to find out.
