Quality Analyst
Level: Experienced
Job Location: Phoenix, AZ - Phoenix, AZ
Position Type: Full Time
Education Level: 4 Year Degree
Salary Range: Undisclosed
Travel Percentage: Negligible
Job Shift: Day
Job Category: QA - Quality Control
Description
Job Title: Quality Assurance Analyst
Position Summary:
This position is responsible for assisting in maintaining the occurrence management system and audit program in accordance with regulatory requirements.
Job Responsibilities:
- Assist with maintaining regulatory compliance to all regulatory and standard requirements applicable to each business unit (CLIA, NYS, CAP, ISO, FDA, IVDR, Etc).
- Maintain portions of the Quality Management System, including but not limited to occurrence management and customer complaints.
- Coordinate with process owners to ensure proper processing and due diligence of customer complaints, nonconformances, and CAPA events.
- Assist and train end users, as needed, regarding the functions of the occurrence management process.
- Oversee the internal and external audit program.
- Use creative problem solving skills to identify, solve or improve processes.
- Review, revise, author and implement new procedures to achieve regulatory compliance and operational efficiency.
Requirements:
Knowledge, Skills and Experience
- List knowledge and skills
Education, Certification, Licensure, and/or Experience
- BS Degree in a scientific discipline (or equivalent work experience)
- 1-3 years of Quality and Regulatory experience in a clinical laboratory.
- CAPA and audit experience is a strong plus.
- Experience working in a regulated environment (CLIA, NYS, CAP, FDA, ISO. Etc)
Physical Demands
- Employee may be required to lift routine office supplies and use standard office equipment.
- Ability to sit for extended periods of time.
- Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.
- Will work at a computer some of the time as well as need to keep inventory and ordering records requiring the use of copiers, fax machines, and PDF scanners.
Required Training
- All job specific, safety, and compliance training are assigned based on the job functions associated with this position.
Other
- This position requires periodic travel and some evenings, weekends and/or Holidays.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
*Interested parties should use the link to apply and email their resume to Kristen Robinson at krobinson@carisls.com. #LI-KR1