Full-Time Quality Assurance Specialist

• Understand the EXCELSIOR™ product, protocol and conduct of clinical trials
• Comply fully with MERIT policies and Standard Operating Procedures (SOPs)
• Conduct internal audits and assist in the development of the internal audit schedule.
• Assist with scheduling and managing audits as assigned.
• Conduct vendor and contractor qualifications and audits including on-site audits, and vendor and contractor maintenance activities.
• Leads the development, recommendation, review and administration of policies, training and SOPs
• Provide training for implementation of internal and regulatory requirements
• Ensure that SOPs are being followed during daily operations
• Responsible for audit responses within framework of internal SOPs and client due dates

• BA or BS degree with related experience in a health care, clinical research or service related environment.
• A minimum of 2 years' experience in quality assurance in the medical device, pharmaceutical or GxP industry.
• Strong interpersonal and organizational skills, excellent attention to detail.
• Proficiency in Microsoft Office software and ability to learn Company specific software.

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