Kelly Scientific Resources has partnered with one of our top clients in Memphis, TN to hire a cGMP Compliance Auditor. This role is direct hire with a nice relocation package.
Reporting directly through the Legal & Compliance function, the cGMP Compliance Auditor will operate from one of the four Outsourcing Facilities. In this role, each Auditor will report directly to the Senior Manager, Compliance & Audits and be responsible for conducting independent internal cGMP and Data Integrity audits to ensure that operations remain compliant with governing standard operating procedures, regulatory requirements, regulatory commitments and, most importantly, FDA’s cGMPs requirements for 503B Outsourcing Facilities.
For the assigned facility, support and implement the Compliance function’s Audit Processes and procedures in accordance with applicable regulatory requirements.
• Perform internal audits including those covering data integrity and OOS investigations.
• Execute the audit per company procedures from planning to closure which includes; issuance of agenda, performance of audit, drafting and issuance of reports, evaluation of investigations and associated corrective actions, verification and tracking of corrective actions and their effectiveness.
• Interview personnel, review production and laboratory data, documents, records and procedures and identify non-compliant conditions or practices.
• Escalate objectionable cGMP practices to Legal & Compliance management
• Prepare and communicate a weekly summary of the compliance state of the facility operations, identification of any non-compliance conditions, adequacy of investigations performed by the facility and any additional training needed for facility personnel.
• Perform any needed follow-up activities including investigations and audits on an as-needed basis
• Provide identified quality metric data for Compliance Program Review meetings
BS/Advanced degree in Chemistry or in Microbiology with
• 5-8 years of external regulatory audit, compliance remediation and internal GMP audit experience
• 5 years’ of specific pharmaceutical GMP experience required
• 3 years demonstrated expertise in laboratory and manufacturing investigations
• Familiarity with aseptic processing environmental monitoring and cleaning, strongly preferred.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly Services
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com
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. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
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