Laboratory Quality Assurance Manager (NYS Clinical Laboratory Technologist )
QUALITY ASSURANCE SPECIALIST
Acutis Diagnostics is headquartered in East Northport, Long Island. The company is a fast-growing clinical laboratory. We pride ourselves on providing expert, accurate, and concise results as a product of our highly talented and passionate team of professionals. We believe the team we build today will be the foundation of our future success.
We are looking for a Quality Assurance Specialist. Plans and directs activities concerned with development, implementation and maintenance of quality standards for laboratory processes, materials and products.
JOB SUMMARY
Coordinates the collection and cataloging of data retrieved from different sections for the laboratory to actively ensure the laboratory in a state of inspection readiness. This data will include quality assessment forms associated with:
- human resources
- facility management – laboratory safety, reagent management, instrument and equipment stewardship
- testing performance – pre-analytical, analytical, post-analytical phases
- quality assurance – quality control processes, proficiency testing, turn-around time
- referral laboratory performance
- response to nonconformity and correction action documentation
RESPONSIBILITIES
- Work closely with the laboratory director to development an effective Quality Assurance program
- Required to maintain laboratory documentation, to ensure traceability from state law to laboratory policies, to procedures, to quality assessment logs
- Oversees collection of the QC documentation
- Continuous reduction of collected data to provide a long term (month to month, year to year) view of laboratory performance
- Work closely with the laboratory director to development, revise, implement and maintain standard operating procedures according to good laboratory practices
- Work closely with the laboratory director in preparing the laboratory for laboratory director audits and inspections by any authorized agencies
- Collect and store documents supporting proper validation of the reagents, supplies and equipment
- Reviews batch records to determine turn-around time meets or exceeds established laboratory criteria
- Reviews QA/QC documentation
- Conducts investigation of the test failures and procedure deviations
- Periodically monitors reagent management and production processes including proper labeling and distribution of supplies and reagents
- Supports Quality Assurance activities related to the development, implementation and maintenance of document control and change control
EDUCATION
- Bachelors in Medical Toxicology or natural sciences discipline required
- Masters in natural sciences discipline preferred
EXPERIENCE
5 – 10 years of prior experience in a clinical laboratory setting with increasing levels of responsibility
QUALIFICATIONS
- NYS Clinical Laboratory Technologist licensed
- ASCP (American Society for Clinical Pathology) certified preferred
SKILLS
- Excellent working knowledge of Microsoft Office
- Excellent written and verbal communication skills
- Interpersonal skills
- Able to organize and prioritize workload
- Able to think quickly and make decisions under pressure
PHYSICAL REQUIREMENTS
- Sitting for an extended period of time
- Repetitive wrist motion
- Audible recognition of alarms
