Works with the management team to maintain and implement quality systems to ensure accreditation standards are followed, conducts and participates in internal and external audits, partakes in document and event management.
The main focus of the individual in this position is to review reports for assay validation conducted on new and existing platforms to ensure that it meets QSEs outlined by CAP/CLIA and NYS. The employee will also assist in the planning and at times help in writing reports. Candidates with validation experience are encouraged to apply.
Job Responsibilities (other duties may be assigned):
Quality Management System
Audits and Assessments
- Assists in the development and maintenance of the quality program for the laboratory in collaboration with the laboratory management team
- Maintains current, in-depth and working knowledge of all accreditation standards including CAP/CLIA, NYS, and others as necessary
- Serves as a resource to the laboratory staff and facilitates comprehension of accreditation standards and regulations
- Attends Quality Assurance meetings
- Ensures that new tests are implemented in concordance with HDL policies and regulations
- Assists in the review of testing documentation such as; Quality Control, Preventative Maintenance, and linearity
- Ensures that testing personnel participate in proficiency testing and analyzes data for shifts or trends
- Ensures that testing personnel complete competency assessments
- Assists with resolution of operational or process problems regarding quality issues.
- Assists and participates in all accreditation inspections
- Maintains records for all inspections and assists the management team in follow-up and corrective action in response to inspection citations
- Conducts internal audits, compiles reports stating improvement options for findings, implements improvement plans and follows up to assure improvements are successful
- Performs and contributes to quality metric analysis and compiles plans and recommendations based on findings
- Coordinates and manages CAP and alternative proficiency testing
- Investigates and documents all proficiency testing events
- Works with the laboratory staff to identify events
- Works with the management team to ensure events are investigated, documented and recommendations are followed
- Participates in tracking and trending events
- Leads the document control process for new and updated documents by maintaining a database and informing the management team for annual review of documents.
- Assists in writing and reviewing documents such as SOPs and training checklists to ensure document standards are met
- Works with the development team and QA manager in document organization of validation projects
- Ensures record storage and retention policies are followed
Position requires a four year degree in clinical laboratory science (CLS), medical technology (MT), chemistry, or biology.
At least 2 years of validation experience in a clinical chemistry laboratory highly preferred
Knowledge of HDL, Inc. and healthcare governing agency policies and procedures
Knowledge of medical terminology
Intrapersonal/human relations skills
Planning and organizational skills
Ability to extract data from conversations and documents
Ability to maintain confidentiality
Must have strong working knowledge of Microsoft Office including Excel
Understanding of basic quality management concepts and regulatory/accreditation requirements.
Must be highly organized, efficient, and able to work both in a team environment and independently exercising strong decision making skills.
Health Diagnostic Laboratory, Inc. - 22 months ago