QA Auditor Iii

1 settimana fa

Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.


Location/Division Specific Information:

EMEA

Discover Impactful Work:


As a QA Auditor III within the Quality Investigation and Support team, you will lead complex, multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.

You will identify issues impacting quality and/or regulatory compliance, determine root cause of non-conformance and develop strategies to address issues.

May perform technical document review and other GxP activities in support of project work or company process. This role plans and delivers billable quality services for clients and projects and may serve as the client contact.

A day in the Life:

  • Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
  • Leads directed site audits, facility, vendor and/or subcontractor audits
  • Provides GxP consultation and support to project teams and external clients
  • Leads process audits and may participate as a coauditor in more complex system audits
  • Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
  • Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
  • Provides mentorship and guidance to junior auditors

Keys to Success:

Education:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience:

  • 5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

Knowledge, Skills, Abilities:

  • Detailed knowledge of
    GCP and appropriate regional research regulations and guidelines
  • Proficiency in a conducting GxP audits
  • Excellent oral and written communication skills
  • Strong problem solving, critical thinking, risk assessment and impact analysis abilities
  • Confirmed experience in root cause analysis
  • Flexible and able to multitask and prioritize complex demands/workload

Our 4i Values:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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