Thermo Fisher Scientific

Thermo Fisher Scientific

QA Auditor II

Richmond, Virginia, USA · Mid · Contract

No sponsorship$15k-$20kDetected 8 hours ago
ComplianceAccessibilityNegotiationAuditingProcess ImprovementUnityClinical TrialsClinical ResearchResearchCommunicationProblem SolvingGxP

About the role

  • We welcome applicants from all locations within the US.
  • At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
  • 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.

Responsibilities

  • Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
  • Perform directed site audits, facility, vendor and/or sub-contractor audits
  • Provide GxP consultation and support to project teams and external clients
  • Lead process audits and may participate as a co-auditor in more complex system audits
  • Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
  • As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
  • Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years').

Requirements

  • Ability to work in an upright and /or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Frequent mobility required.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand
  • with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Ability to multi-task.
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Must be legally authorized to work in the United States without sponsorship.
  • Must be able to pass a comprehensive background check, which includes a drug screening.

Skills

  • Thorough knowledge of GxP and appropriate regional research regulations and guidelines
  • Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
  • Excellent oral and written communication skills
  • Strong problem solving, risk assessment and impact analysis abilities
  • Solid experience in root cause analysis
  • Above average negotiation and conflict management skills
  • Flexible and able to multi-task and prioritize competing demands/work load

Compensation

  • Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.

Benefits

  • Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
  • Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts.
  • For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments.
  • Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings Education and Experience:
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job
  • Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Company info

  • Our Mission is to enable our customers to make the world healthier, cleaner and safer.
  • Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer.
  • Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

Equal opportunity

  • Please contact us to request accommodation.
  • Thermo Fisher Scientific is an Equal Opportunity Employer.

Visa & Work Authorization

  • Must be legally authorized to work in the United States without sponsorship.

This listing is sourced directly from Thermo Fisher Scientific's careers page and normalized into a canonical job model.