Assoc QC Auditor

Pharmaceutical Product Development (PPD)

TX-Austin-Austin TX Metro Center Dr 2


The Quality Control (QC) Auditor is responsible for ensuring the quality and integrity of data and information by conducting timely and cost effective audits of diverse scope against customer, sponsor, PPD and regulatory requirements and specifications. The QC Auditor may provide review services for CDS, Biostatistics and Data Management, Regulatory Affairs, Phase I, or any other PPD department as requested.The Quality Control (QC) Auditor is responsible for ensuring the quality and integrity of data and information by conducting timely and cost effective audits of diverse scope against customer, sponsor, PPD and regulatory requirements and specifications. The QC Auditor may provide review services for CDS, Biostatistics and Data Management, Regulatory Affairs, Phase I, or any other PPD department as requested.Education and Experience:Bachelors degree2-5 years relevant experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.

Knowledge, Skills and Abilities:Computer skills to include, but not limited to Microsoft Word, Excel, Access and some experience with entry of data into a databaseThe QC Auditor must have a working knowledge of FDA regulations and guidelines, Good Clinical Practices, and PPD SOPs/Working Practice Documents.Must have the ability to analyze and interpret data.Requires independent judgment and decision making in conducting audits and recommending a course of action for discrepancy resolution.Attention to detail is critical for performance criteria and conducting thorough audits.Must be able to effectively communicate with diplomacy at all levels of personnel.Must possess good interpersonal skills. Initiative is required for trouble shooting.Must be able to function in the role of mentor/trainer for ongoing process improvement issues wtih the study teams.The QC Auditor may work on multiple concurrent projects, therefore, must be able to plan workload (with minimal assistance) by as much as 6-12 months for a specific project or projects.Must be able to prioritize activities.Infrequent supervision of the QC Auditor is required for the completion of daily/weekly tasks.Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Education and Experience:Bachelors degree2-5 years relevant experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.

Knowledge, Skills and Abilities:Computer skills to include, but not limited to Microsoft Word, Excel, Access and some experience with entry of data into a databaseThe QC Auditor must have a working knowledge of FDA regulations and guidelines, Good Clinical Practices, and PPD SOPs/Working Practice Documents.Must have the ability to analyze and interpret data.Requires independent judgment and decision making in conducting audits and recommending a course of action for discrepancy resolution.Attention to detail is critical for performance criteria and conducting thorough audits.Must be able to effectively communicate with diplomacy at all levels of personnel.Must possess good interpersonal skills. Initiative is required for trouble shooting.Must be able to function in the role of mentor/trainer for ongoing process improvement issues wtih the study teams.The QC Auditor may work on multiple concurrent projects, therefore, must be able to plan workload (with minimal assistance) by as much as 6-12 months for a specific project or projects.Must be able to prioritize activities.Infrequent supervision of the QC Auditor is required for the completion of daily/weekly tasks.Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.


2020-08-04 00:00:00


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