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Job Description
Main Duties:
- Develop, implement, communicate, and maintain quality plan.
- Define and maintain QA/QC objectives, targets, and processes and review new targets, protocols, processes, equipment, supplies, and technologies for quality standards.
- Implement the corrective action when necessary.
- Assist in the process of achieving ISO 15189 Standard accreditations.
- Establish QC/QA documentation procedures and monitor QA/QC performance on a variety of systems by gathering relevant data from electronic and hard-copy sources.
- Assure proper qualification, maintenance and calibration of lab equipment and on-line test instruments.
- Occasional travel to branches to supervise their accreditation.
- Perform regular internal quality audits, recommend changes, and initiate corrective or preventative actions when appropriate.
- Identify relevant quality related training needs and deliver training to personnel.
- Maintain the document control and versioning process.
- Perform all other duties as assigned.
Job Requirements
Qualifications:
- Graduation from an accredited college or university (science or preferred medicine )
- Graduated in Project Management or Quality Management and/or Clinical Laboratory Management or related field; Master’s Degree preferred.
Work experience
- Minimum of three years post-graduate experience in a life science/research Quality Control or Quality Assurance clinical laboratory developing operational performance metrics and meeting performance requirements.
- Prior experience in a clinical laboratory setting. Experience with a variety of laboratory quality management systems, e.g., CAP, ISO, and CLIA.
- Demonstrated knowledge of one or more of the following topics: consenting patients; regulatory affairs in clinical laboratory, processing, storage, and/or shipping of biological specimens; managing and designing databases and inventories; performing data checks; and/or document version control.
Skills
- Ability to function independently and as a member of a large team; motivate people to achieve excellence; work with multiple leadership and staffing levels to achieve quality management goals.
- Must have excellent communication skills both verbal and written.
- Ability to train personnel on quality standards and practices.
- Experience qualifying, maintaining and/or calibrating equipment strongly preferred.
- Proficient in Microsoft Office Suite, including Word, Excel, SharePoint, Outlook, and Access, with experience with project management software and maintenance and development of electronic databases preferred.
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