GLP QA Officer I

Full Time Madison WI Covance

Job Overview:

 

GLP QA Officer I

 

  • Performs protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable SOP and regulatory requirements.
  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
  • Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).
  • Notifies management of service failures. 
  • Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.
  • Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization.
  • Performs SOP reviews.
  • Starts to participate in internal facility and supplemental inspections, under supervision.
  • Starts to deliver basic quality/regulatory training, under supervision. 
  • Identifies opportunities for process improvement and harmonization efforts that promote best practices. 

 

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Education/Qualifications:

  • Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)
  • Recognized qualifications to support proficiency in basic numeracy and literacy (precise details will be dependent on the country of location).
  • Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)
  • In exceptional circumstances, directly relevant previous experience may be substituted for degree requirements.

Experience:

  • At least 1 year of experience as a quality auditor in a GxP-regulated environment.

To apply for this job please visit topspotjobs.com.