Sonya Gray

· Complete individual and team assignments within pre-set deadlines.

· Meet or exceed the expectations of our customers, both internal and external, through teamwork and commitment to preparation of a product of superior quality, while being conscious of corporate financial goals.

• Entry of manually collected data into the computer and/or use of word processing software to generate report tables from this data.

· Proof/verify/perform quality control (QC) of manually generated report tables or manually entered data against raw data.

· Perform calculations on raw data.

· Gather information for special Sponsor requests when required.

• Review study data against the Protocol/Study Plan, standard operating procedures (SOPs) and GLPs and take appropriate action to any correct deficiencies.
• Execution of statistical analysis programs for appropriate data sets.
• Respond to quality assurance inspection audits reports, as well as comments from report production peer reviewers, the Study Director, and Sponsors.

· Generate GLP compliant status/interim reports, draft, and final reports within scheduled time frames in a manner consistent with the specifications of Sponsors, regulatory agencies, and the company’s requirements.

• Prepare the data packages for archival and coordinating transfer to the archives within GLP specified timeframe.
• Securely maintain raw data for completed studies until submission to archival storage.

• Audit draft/final protocols, laboratory procedures, study data and draft/final study reports for on-going and completed toxicology studies for adherence to Protocols, SOPs, the applicable United States of America and international GLPs.
• Report findings to Study Directors and Management on facility and study quality compliance issues, and resolution of the same.
• Coordinate and participate in the training of newly hired Quality Assurance Auditors.
• Interact with senior technical staff and scientific management to facilitate and optimize quality compliance practices in overall study conduct, data collection and reporting.
• Assist departments in resolving compliance issues and provide guidance including interpretation of the regulations.
• Inspect all departments in the facility including all their records & equipment on an annual basis for compliance with the SOPs and GLPs.

· Complete individual and team assignments within pre-set deadlines.

· Meet or exceed the expectations of our customers, both internal and external, through teamwork and commitment to preparation of a product of superior quality, while being conscious of corporate financial goals.

• Entry of manually collected data into the computer and/or use of word processing software to generate report tables from this data.

· Proof/verify/perform quality control (QC) of manually generated report tables or manually entered data against raw data.

· Perform calculations on raw data.

· Gather information for special Sponsor requests when required.

• Review study data against the Protocol/Study Plan, standard operating procedures (SOPs) and GLPs and take appropriate action to any correct deficiencies.
• Execution of statistical analysis programs for appropriate data sets.
• Respond to quality assurance inspection audits reports, as well as comments from report production peer reviewers, the Study Director, and Sponsors.

· Generate GLP compliant status/interim reports, draft, and final reports within scheduled time frames in a manner consistent with the specifications of Sponsors, regulatory agencies, and the company’s requirements.

• Prepare the data packages for archival and coordinating transfer to the archives within GLP specified timeframe.
• Securely maintain raw data for completed studies until submission to archival storage.

• Maintain records of various study activities.
• Follow established protocols, SOPs, GLPs, animal welfare requirements, United States Department of Agriculture (USDA) regulations and guidelines.
• Scheduled study related events based on protocol requirements.
• Designed study forms to ensure that the data is recorded clearly and traceable.
• Train and access the level of proficiency of technicians to perform study related and departmental tasks.
• Communicated study related issues to the Study Director
• Documented deviations from the protocol and SOPs by accurately describing the events.