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Qa Assoc Sr GMP _ Quality Associate III GMP Auditing
(919) Area Code Raleigh/Durham Area
Sr Associate III, GMP Auditing
As a key contributor within the Corporate Quality organization, the individual will be primarily responsible for performing external audits of our vendors and suppliers. The individual will have the ability to effectively communicate compliance issues and expectations with our internal customers, management, and external vendors/ suppliers. The individual will have the ability to perform risk assessments and gap analyses for compliance and business risks.
• Coordinate, conduct, and provide follow-up for on-site audits and/or assessments of external suppliers/ vendors/ service providers such as contract manufacturing organizations, suppliers of raw materials, laboratory operations, logistics providers, and GMP service providers.
• Assembly and coordination of the audit team, preparation of the audit plan, leading the audit, writing audit reports and follow-up letters.
• Ensure that the appropriate remediation/ CAPAs are in place for any GMP deficiencies found during audits.
• Participation in vendor change notification assessments
• Participation in creation and approval of vendor quality agreements.
• Perform material/ vendor risk assessments
• Possess and maintain knowledge of current global GMP regulatory requirements and industry trends to ensure compliance at external vendors
Responsibilities also include successfully completing and maintaining as current job training requirements.
Minimum 10 years related compliance or auditing experience in the pharmaceutical and/or biotechnical arenas.
Previous experience in drug substance/drug product manufacturing, Quality Control and/or Quality Assurance is required.
cGMP auditing experience is required. Certified Quality Auditor (CQA) designation is beneficial.
General knowledge of regulatory requirements for the pharmaceutical/ biotechnology industry is required.
The individual must have excellent communication skills, both verbal and written, and have the ability to work independently and in a team environment.
The individual must have excellent typing skills and be proficient in the use of Microsoft Word, Excel and Powerpoint applications.
Domestic and international travel expected for this position is ~50%.
BS or advanced degree in a scientific field
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