Principal GCP Quality Assurance Auditor

6 days ago

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pfm medical, inc.

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Medical Device Manufacturing

11 - 50

Description

• Oversee quality and compliance activities during clinical studies • Serve as a subject matter expert for clinical project teams • Support the Quality Management System including SOPs, training and CAPA • Conduct internal audits of quality systems and host client audits • Monitor quality systems to provide feedback on compliance risks

Requirements

• 5 years of experience • Working knowledge of GCP/ICH guidelines and FDA regulations • Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits • Bachelor's degree in a science, healthcare, or related field; combination of qualifications and equivalent relevant experience may be accepted as an alternative • Availability to travel up to 25% domestically and/or internationally

Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave • Vacation