Quality Assurance Specialist
Posted on: January 16, 2021
Quality Assurance Specialist
Help us improve access to life-changing therapies that can
transform human health
We are Cytiva, a global provider of technologies and services that
advance and accelerate the development and manufacture of
therapeutics. Formerly part of GE Healthcare, we have a rich
heritage tracing back hundreds of years, and a fresh beginning
Our customers undertake life-saving activities. These range from
fundamental biological research to developing innovative vaccines,
biologic drugs, and novel cell and gene therapies. Our job is to
supply the tools and services - the pots, pans, soups and sauces -
they need to work better, faster and safer, leading to better
We are looking for a Quality Assurance Specialist to work with our
expert Cell Culture team of nearly 7,000 employees across the
world. Do you have a passion for quality? Then we would love to
hear from you.
What you ll do
- Responsible for ensuing compliance in accordance with
documented procedures for all aspects of operations as well as
- Reviews production and quality documentation for adherence to
Good Documentation Practices
- 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
- 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
- Ensures process compliance through the development of simple
yet comprehensive procedures, work instructions, flowcharts, forms,
templates, checklists, worksheets, and other product/process
- 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 (high school
diploma/GED with 2-4 years of relevant work experience may be
substituted for education).
- Demonstrated understanding or aptitude to understand regulatory
requirements including FDA CFR 21 820 and ISO 13485.
- Demonstrated proficiency in word processing, spreadsheet, and
- Strong interpersonal communication skills with the ability to
effectively communicate and work inter-departmentally.
- Ability to accomplish goals and work with minimal
- 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
- Maintains a positive attitude, is self-motivated, and works
well independently and as part of a team.
- Flexible schedule which will include consistently working
- Quality Assurance experience in a regulated industry strongly
Who we are:
Whatever your role, we bring purpose and challenge into our
everyday work. If you are driven to make the world a better place
thanks to science and medicine, you ll feel right at home here. If
you re flexible, curious and relentless, you ll belong. If you are
excited about a global culture, this can be the place to further
Want to know more? Experience life at Cytiva on our Careers
website, Instagram channel and LinkedIn page!
Cytiva is a 3.5 billion USD global life sciences leader with over
7000 associates across 40 countries who are dedicated to our
mission to help us improve access to life-changing therapies that
transform human health. As a trusted partner to customers that
range in scale and scope, Cytiva brings efficiencies to research
and manufacturing workflows, ensuring the development, manufacture
and delivery of transformative medicines to patients.
Cytiva is part of the Danaher family of companies, a global science
and technology innovator committed to helping customers solve
complex challenges and improving quality of life around the
Danaher Corporation and all Danaher Companies are equal opportunity
employers that evaluate qualified applicants without regard to
race, color, national origin, religion, sex, age, marital status,
disability, veteran status, sexual orientation, gender identity, or
other characteristics protected by law. The EEO is the Law poster
is available here.
Keywords: Cytiva, Logan , Quality Assurance Specialist, Professions , Logan, Utah
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