An individual in this role verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations (GLP and/or GCP) by performing study protocol, data, report, in-lab phase inspections where applicable, for a specific study type. A GLP/GCP QA Officer 1 will be gaining experience by participating in internal facility and/or supplemental inspections (under some supervision) and begin to review SOPs. They will identify opportunities for process improvement and harmonization efforts to promote best practices, and will be starting to gain experience in delivering training in basic quality/regulatory matters.

• 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.
• Performs other related duties as assigned.

• Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)
• Recognised 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.

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