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JOB SUMMARY
The QA Analyst supports the Executive Director of Compliance and development in all aspects of the quality system operations. The primary function will require the internal auditing and daily maintenance/review of the quality system processes to ensure compliance and improvements to the system.
RESPONSIBILITES
- Maintains annual audit schedules and communicates with departmental personnel on planning of the audits
- Analyses and maintains processes to ensure compliance, effectiveness and improvements to the quality system
- Performs internal audits of the quality system processes
- Assesses compliance to regulatory requirements
- Follow up to training and verifies compliance through follow-up checks and ongoing training to reemphasis system requirements
- Provides input details for yearly management reviews, compiling information on quality system compliance and issues, trend evaluations
- Perform other duties as needed
KNOWLEDGE SKILLS AND ABILITIES REQUIRED
- 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.
- The ability to work effectively and interact daily in a cross-functional setting
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.Travel: MinimalThe above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.
They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.Requirements3-5 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. The ability to work effectively and interact daily in a cross-functional setting
