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Ex FDA Investigator
4 months ago
Our client, a leading Biotechnology company is seeking an FDA Investigator to support audit/inspection readiness programs and drive
Job Title: Ex FDA Investigator
Location: Hayward, CA
Pay Range: $95-$125/hr
What’s the Job?
- Preparing for, conducting, and reporting on mock FDA inspections and compliance evaluations in support of ANDA, NDAs, and BLA submissions
- Evaluation of inspection readiness programs including providing recommendations for improvement
- Drafting or reviewing responses to FDA 483 observations, warning letters or similar documents as needed
- Participate in complex root cause investigations including manufacturing deviations and OOS investigations
- Conduct gap assessment of quality management systems and provide prioritized remediation recommendations
What’s Needed?
- B.S. life sciences and 10 years’ relevant experience
- MUST BE a Former FDA Employee and experience as an investigator
- Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients
- Expert knowledge of current FDA, ICH, and USP laws, regulations, guidances and expectations.
- Expertise in reviewing regulatory filings and the drug, biologic or device review and approval process (DMFs, ANDAs, NDAs, BLAs, PMAs, etc.)
- Experience with planning and conducting FDA inspections/mock audits to include GMP/GLP audits
- Experience with data integrity and electronic data reviews
If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
