Quality Operations Manager (Contract)

• Bachelor’s degree, preferably in a scientific/healthcare field with minimum 5-7 years of experience in related area. Knowledge of FDA regulatory requirements is required.
• Experience as a GCP focused clinical QA Auditor is preferred, or at a minimum, quality assurance experience via clinical site, CRO, and/or sponsor
• Familiar with a variety of concepts, practices and procedures in clinical research. Strong writing, presentation, and communication skills. Works effectively and efficiently to handle multiple tasks simultaneously with strong organizational skills. Ability to facilitate a teamwork philosophy.

Toperform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Ability to enter data accurately including experience working with Microsoft Office. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to facilitate a teamwork philosophy with a positive attitude. Strong interpersonal skills. Exceptional attention to detail. Excellent organizational skills.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Work in a home environment where the noise level is usually largely controlled by the employee
• and a travel environment where the noise level is usually moderate to high. Employee is subject to many interruptions
• and handling multiple tasks simultaneously while performing assigned duties.