About the role
- Supports the Executive Director of Compliance and development in all aspects of the quality system operations.
- Internal auditing and daily maintenance/review of the quality system processes to ensure compliance and improvements.
- Maintains annual audit schedules and communicates with departmental personnel on audit planning.
- Analyzes and maintains processes to ensure compliance, effectiveness, and improvements.
- Performs internal audits of the quality system processes.
- Assesses compliance with regulatory requirements.
- Follows up on training and verifies compliance through follow-up checks.
Requirements
- 3-5 years’ experience performing quality system audits in a healthcare and/or health research environment.
- Experience establishing compliance with organizational regulations
- Great attention to detail
- Exceptional verbal and written communication
- Knowledge of basic validation concepts.
- Strong analytical and problem-solving skills.
- Use of initiative, self-motivation, planning and organizational skills.
- Ability to work effectively and interact daily in a cross-functional setting.
- Some flexibility in hours allowed
- Work environment free of discrimination and harassment.
- Equal employment opportunity for all employees.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality system auditscompliance analysisinternal auditingregulatory compliancevalidation conceptsprocess improvementaudit planning
Soft skills
attention to detailverbal communicationwritten communicationanalytical skillsproblem-solving skillsinitiativeself-motivationplanning skillsorganizational skillscross-functional collaboration