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
2-5 years relevant experience
Or 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 database.
The 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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.