Sr. QA Engineer - Quality Assurance
Company: Cytiva
Location: Muskegon
Posted on: January 27, 2023
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Job Description:
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 are pioneering the future of
science and medicine, developing products that enable researchers
in the fight to save lives.What you'll doSupport the execution the
QMS implementation action plan defined by the QARA Project
leader.Accountable for developing and maintaining the Site QMS
training matrix , be the Subject Matter Expert (SME) in the
eLearning system, Cytiva Learning (Cornerstone).Accountable for QMS
trainings assignments as well as support site Quality induction
activities.Accountable for QMS document management, including but
not limited to; leading the site document review board, authoring
of local QMS work instructions, liaising with the Global QMS team
on Global documentation updates and acting as the site
administrator for the Cytiva electronic documentation management
system (eDMS), Veeva Quality Docs.Be the local system administrator
for the Cytiva eQMS; deviations, investigations, CAPAs, Changes
(Change Controls) and internal audits. As system administrator,
represent the site in global superuser forums ensuring site needs
are identified, system updates are implemented and communicated.
Lead system specific training and approve system access for
associates.Responsible for on-site Quality Assurance support to the
technology transfer project for all quality related topics.You will
be part of our ongoing security of supply initiative to build a new
chromatography media manufacturing site, the product transfer from
our manufacturing site in Uppsala Sweden and to build up the
Quality Management System for the site.Who you areMinimum,
Bachelor's degree from an accredited University or College,
preferably in a Science or Engineering disciplineA minimum 5 years
working experience in Quality Assurance/Quality Engineering within
Life Science, Medical Device or Biopharma manufacturing
environmentsComprehensive understanding of ISO 9001 & ISO 13485
requirements Understanding of GMP requirements, desiredExperienced
in working cross - functionally, both locally and
globallyExperience of working with implementing Quality Management
Systems, and working with documents and training desiredStrong
analytical- and problem-solving skillsStrong communication skills
(written and oral).Strong interpersonal skills, including
escalation managementConfident when working independently and as
part of a teamStrong PC literacy required; MSOffice skills
(Outlook, Word, Excel, PowerPoint)Travel to Uppsala will be
required.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.Danaher
Corporation and all Danaher Companies are committed to equal
opportunity regardless of race, color, national origin, religion,
sex, age, marital status, disability, veteran status, sexual
orientation, gender identity, or other characteristics protected by
law. 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.The EEO
posters are available here.We will ensure that individuals with
disabilities are provided reasonable accommodation to participate
in the job application or interview process, to perform crucial job
functions, and to receive other benefits and privileges of
employment. Please contact us at applyassistance@danaher.com to
request accommodation.If you've ever wondered what's within you,
there's no better time to find out.
Keywords: Cytiva, Grand Rapids , Sr. QA Engineer - Quality Assurance, Other , Muskegon, Michigan
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