Quality Control Specialist
Company: Latitude, Inc.
Location: Sanford
Posted on: August 3, 2022
Job Description:
Pay: 35-45/hr (Salaried with overtime opportunity) -The Quality
Control Specialist I will:
- Perform quality control procedures for clinical trials managed
by the Clinical Operations department; review all study
documentation for accuracy, consistency, and completeness.
- Work with the QC manager to schedule live and post-visit QC
activities to ensure that all requirements of the QC plan are
executed
- Work with QC manager and QC Specialists to ensure study
specific QC plans are followed during clinical trials, ensuring QC
processes are in alignment with Cliantha Research SOPs and study
protocols
- Assist with the development of; and utilize QC checklists and
other QC tools designed to document/track the QC review
process
- Communicate findings from QC reviews to the appropriate
Clinical Operations staff via QC summaries, reports or verbally as
required under the guidance of QC manager/QC Specialists.
- With some guidance, follow-up on all QC findings, as required,
until a satisfactory resolution has been determined.
- Maintain a working knowledge of relevant US, Canadian and
European GxP regulations as well as ICH regulations.
- Ensure compliance with appropriate Cliantha Research SOPs, GCP
and ICH guidelinesWhat youll bring:To perform this job
successfully, an individual must have:
- Prefer a bachelors degree, with a minimum of two years of
college, university, or technical school education in life science
or relevant scientific discipline.
- 0-2 years of relevant experience in a clinical research
setting
- Displays a basic ability to identify, anticipate and define
issues in a timely manner and to understand the potential impact of
issues. Sufficient awareness to notify a supervisor when the
problem is beyond the individuals ability to resolve, or as
otherwise appropriate. Knowledge of the IRB process, ICH GCP and
FDA requirements
- Strong documentation skills and high attention to detailPowered
by JazzHR
Keywords: Latitude, Inc., Sanford , Quality Control Specialist, Other , Sanford, Florida
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