Job description

The QC/QA Assistant will help the laboratory execute quality centric goals and objectives while constantly maintaining regulatory compliance for the laboratory that is CLIA certified and CAP accredited. In addition to improving overall quality, you will serve in a coaching capacity for the operational leadership in the creation and implementation of processes, policies, and procedures.

Major Duties and Responsibilities

Responsibilities:

Prepare laboratory reports for quality assurance, accuracy, completeness, and reasonableness of data.
Verify the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
Oversees the daily QC/QA processes of the laboratory departments.
Assurance and safety issues especially sampling or analytical problems and use of laboratory chemicals, equipment, and supplies.
Maintain and establish a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.
Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
Identify training needs and ensure everyone performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
Assist the Lab Operations Director with establishing and maintaining Quality Control/Quality Assurance, and Safety programs in accordance with all regulatory standards.
Assess the validity of the results through the evaluation of quality control and quality assurance documentation.
Maintain a close working relationship with the laboratory operations director and other senior level/executive leadership.
Perform other work-related duties.

Job Specifications

Bachelor’s degree in biology, chemistry, or related subject.
3-5 years in quality control and quality assurance in a medical testing laboratory setting is required.
Laboratory experience is required.
Experience working and communicating with all levels within an organization.
Experience in document control establishment and maintenance.
Proficient in Microsoft Excel.
Must adhere to all HIPPA regulations, OSHA and CLIA rules and regulations for laboratories including use of PPE.
The ability to multitask and manage daily changes in workflow with flexibility and good judgement.
The ability to work in a changing team environment, as well as independently, with efficiency, accuracy, and professionalism.
The ability to be meticulous, with high attention to detail.
Must be flexible and willing to work in areas and on problems that may not normally be part of the position but required for the efficient operation of the business.

SpectraCell Laboratories, Inc.

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QC/QA Assistant