Tracy Doty Email & Phone Number

Responsible for organizational quality, regulatory and compliance program. Maintain working knowledge of applicable regulations for the application of development, implementation, ensuring adherence to company policies, standard operating procedures, compliance tools, Working Instruction Documents (WID) and local requirements and regulations. Provide.

Lawrence, Kansas, US

Lawrence, Kansas, US

Lees Summit, MO, US

• Generate and maintain all aspects of the quality program as required by cGMPs and FDA guidelines
• Ensure quality testing is in compliance with current regulatory requirements
• Serve as document control supervisor
• Responsible for administering, updating, maintaining, and documenting Excite’s training program and ensuring all personnel have had the appropriate training according to their job duties
• Periodically perform internal audits of internal practices and procedures as they apply to cGMP compliance and internal SOP requirements
• Oversee the quality aspects of manufacturing- including batch record conformance to requirements, cleaning procedures are in place, etc.

• Generate and maintain all aspects of the quality program as required by ISO, cGMP, and FDA guidelines
• Develop and maintain specifications for raw materials and raw material suppliers
• Establish quality parameters and specifications for in-process and finished products and packaging
• Ensure all quality testing is in compliance with current regulatory requirements
• Perform and/or review quality assurance tests on raw materials, in-process, finished products, and packaging where applicable
• Serve as document control manager, including maintenance of current and archived controlled documents, issuance of controlled documents, and management of document change requests

• Serve as the focal point for ce2l quality control (QC) and quality assurance (QA) program and be responsible for the oversight of QC/QA activities. This includes implementing, maintaining, and improving the quality.
• Ensuring all personnel understand their contributions to the quality system;
• Ensuring communication takes place at all levels within the laboratory regarding the effectiveness of the quality system.
• Evaluating the effectiveness of training;
• Developing and updating a comprehensive quality assurance manual (QAM) for the laboratory;
• Preparation, review, and/or approval of laboratory Standard Operating Procedures (SOPs);

Coordinate with vendors any quality related activities such as changes to methods, specifications, batch records, protocols, and method transfers, etc.Support the validation of processes including approval of sampling protocols, process protocols, and reportsManage change controls including QA evaluation and approval, approval/ rejection of vendor change.

Verona, VR, IT

Review and approve non-conformance/ deviation reportsPerform root cause analysisResponsible for the Corrective and Preventive Action program and related processes and the implementation of a coordinated approach to systems improvementAssure that corrective and preventive actions are completed as requiredResponsible for the maintenance of.

Perform batch record review and finished product release dispositions, including accept/reject decisionsPerform dispositions of incoming drug substances, raw materials, components, and in-process materials and finished drug productPerform internal and external audits including developing scope, conducting audit, writing reports, and approving corrective.

Conduct qualification of cleaning processes, equipment, facilities, lab instruments, and computer systems Conduct process validation for products manufactured by Martec Conduct change controls of qualified equipment Implement, review, and update SOPs governing validation Implement, review, and update master validation plans Coordinate the environmental.

Raleigh, North Carolina, US

Determine case report form requirements in accordance with study protocol, project plan, and guidance from PRA and clientDevelop data management plan by providing professional input and drafting sections as assignedParticipate in the validation of the clinical databaseProcess and review CRF dataGenerate and resolve queriesPerform and document quality.

Paris, France, FR

Assure the quality of products by monitoring compliance with global, site, and unit guidelines Provide quality perspective to the technology transfer and development of new products at the KC SiteInvestigation of customer complaintsDevelop and conduct trainingReview and approve procedures and change control documentationPerform and/or review/approve.

Paris, France, FR

• Investigate and resolve production problems, characterize raw materials, respond to customer complaint samples
• Responsible for the safety training for the laboratory associates as the Chemical Hygiene Officer in 2001

Perform release testing on routine production and stability samples and enter the data into the SQL-LIMS systemPerform review of laboratory documentation including hardcopy data and data entered into SQL-LIMS Coordinate with manufacturing the swabbing and testing of samples after equipment cleans

Perform generic and failure analyses on coatings using FTIR microscopyPerform elemental analysis on paint chips