Quality Assurance Specialist-Temporary

Job Description

• Review study reports, trial files and any other supportive documents for alignment with the study protocol and compliance with GCPs, GLPs, and CRL SOPs.
• Review documents such as informed consent forms and IRB approval documentation.
• Notify appropriate individuals if deviations from the protocol or SOP are found, and ensure proper documentation is generated.
• Meet with staff as needed to discuss or review study folders and/or final reports, and any issues found within them.
• Maintain independence and separation from lab operations to ensure unbiased review of study data.
• Maintain a safe, fast-paced and positive working environment

Qualifications

• Associate’s degree in science, or equivalent, and one year relevant work experience.
• At the discretion of Senior Management, additional education may qualify an individual with less experience
• Strong communication skills
• Good team player
• Strong work ethic
• Detail oriented
• Knowledge of GCP and GLP guidelines preferred
• Previous laboratory experience preferred

Additional Information

Position is Temporary. Candidates currently living within a commutable distance of Austin, TX are encouraged to apply.