What are the responsibilities and job description for the Quality Assurance Specialist position at Cytiva?
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.
What you’ll do
Responsible for ensuring compliance in accordance with documented procedures for all aspects of operations as well as functional responsibility.
Reviews production and quality documentation for adherence to Good Documentation Practice requirements and performs final batch release of intermediate and finished product in a timely, compliant manner.
Perform quality audits and internal audits with real-time coaching/mentoring and follow-up as needed.
Ensures deficiencies discovered are addressed and corrected as needed.
Review and approval of deviation cases and corrective and preventive action plans (CAPA) including the use of problem-solving tools (5-Why, Cause and Effect, etc.) and technical writing.
Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product/process related documentation.
Performs a broad variety of tasks in support of quality and production as assigned by the departmental manager.
Who you are
Bachelor’s degree from an accredited institution (Experience may be considered in lieu of a degree).
Demonstrated understanding or aptitude to understand regulatory requirements including FDA 21 CFR Part 820, ISO 13485, and ISO 9001.
Demonstrated proficiency in word processing, spreadsheet, and presentation software.
Strong interpersonal communication skills with the ability to effectively communicate and work interdepartmentally.
Ability to accomplish goals and work with minimal supervision
Demonstrated understanding or aptitude to understand continuous quality/process improvement tools (5S, SPC, DMIAC, root cause analysis tools, etc.).
Positive, team-player that consistently goes above and beyond.
Maintains a positive attitude, is self-motivated, and works well independently and as part of a team.
Three years of relevant work experience.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.
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.
What you’ll do
Responsible for ensuring compliance in accordance with documented procedures for all aspects of operations as well as functional responsibility.
Reviews production and quality documentation for adherence to Good Documentation Practice requirements and performs final batch release of intermediate and finished product in a timely, compliant manner.
Perform quality audits and internal audits with real-time coaching/mentoring and follow-up as needed.
Ensures deficiencies discovered are addressed and corrected as needed.
Review and approval of deviation cases and corrective and preventive action plans (CAPA) including the use of problem-solving tools (5-Why, Cause and Effect, etc.) and technical writing.
Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product/process related documentation.
Performs a broad variety of tasks in support of quality and production as assigned by the departmental manager.
Who you are
Bachelor’s degree from an accredited institution (Experience may be considered in lieu of a degree).
Demonstrated understanding or aptitude to understand regulatory requirements including FDA 21 CFR Part 820, ISO 13485, and ISO 9001.
Demonstrated proficiency in word processing, spreadsheet, and presentation software.
Strong interpersonal communication skills with the ability to effectively communicate and work interdepartmentally.
Ability to accomplish goals and work with minimal supervision
Demonstrated understanding or aptitude to understand continuous quality/process improvement tools (5S, SPC, DMIAC, root cause analysis tools, etc.).
Positive, team-player that consistently goes above and beyond.
Maintains a positive attitude, is self-motivated, and works well independently and as part of a team.
Three years of relevant work experience.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.
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