Scientific Director

Navis Clinical Laboratories Inc -
Tacoma, WA

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Job Details

Part-time | Full-time

Qualifications

CAP guidelines
Assay development
Managing laboratory teams
Doctor of Philosophy
CLIA regulations
Verification of laboratory test methods
Typing
Clinical quality assurance standards
Regulatory compliance analysis
Test validation method
Legal compliance
Toxicology and drug testing
Quality data entry
Validation design

Full Job Description

Position Summary:

The Scientific Director is designated as the senior lab employee at Navis Clinical Laboratory and is charged with providing services to all lab departments and personnel. This position may be designated as either full-time or part-time. The Scientific Director must possess extensive experience in high-complexity toxicology testing, assay development, laboratory operations, and regulatory compliance. Holds the title of Responsible Person (RP) for the purposes of certification such as CAP (College of American Pathologists – High Complexity), CLIA and New York State.

The Scientific Director reports to the Chief Executive Officer.

Essential Functions:

Directs, reviews and approves all laboratory processes, procedures, SOP’s, standard work, quality assurance and related functions.
Performs highly complex operations to test and confirm/non-confirm initial screen results; design and development of new assays, validation of all testing protocols.
May perform various research and development (R&D) duties including testing of various confirmation methods, performing validation sequences, recommending new or modified assays, documenting existing or new processes or procedures and related duties.
Assures Chain of Custody (CoC) procedures are followed at all times. Responsible for the policies on quality and accuracy of reporting test results.
Maintains appropriate communications both intra and inter-departmentally. Assures appropriate health and safety programs are in place and practiced.
May be required to testify on behalf of the lab or client in the event of legal proceedings and/or prepare litigation packets.
Follows all laboratory policies and procedures; adheres to all health and safety standards.
Participates with company strategies including 5s, Lean and the elimination of waste.
Provide effective and efficient administrative direction of the laboratory, including budget planning and budget control in conjunction with the individual(s) responsible for financial management of the laboratory.
Ensure that sufficient qualified personnel are employed with documented training and/or experience to supervise and perform the work of the laboratory.
Provide educational direction to laboratory staff.
Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, to provide remedial training or continuing education to improve skills.
Specify in writing the responsibilities and duties of all laboratory personnel, including assistant directors.
Promote a safe laboratory environment for personnel and the public.
Ensure that an approved procedure manual is available to all personnel.
Ensure testing systems provide quality laboratory services for pre-analytic, analytic, and post-analytic phases of testing.
Ensure that test methods selected have the capability of providing quality results.
Ensure verification procedures used are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method.

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Ensure that reports of test results include pertinent information required for interpretation.
Assure that the laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System.
Provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient results interpretation.
Ensure that the laboratory is enrolled in proficiency testing programs for the testing performed and that the laboratory adheres to the program’s administrative and technical requirements.
Select all reference laboratories.
Maintain an effective working relationship with applicable accrediting and regulatory agencies, administrative officials, and the medical community.
Ensure that a general supervisor provides on-site supervision of high complexity test performance by certain personnel.

Additional Duties:

All other duties as assigned

Education and Experience:

PhD from an accredited institution with a relevant chemical, physical or biological science major, required
Four years of postdoctoral training and/or experience in an acceptable laboratory of which two or more years of training and/or experience must be demonstrated in the methods and techniques currently in use in the permit category(ies) sought and two or more years of experience in general laboratory management, required
Minimum of four (4) years of experience in a high-complexity laboratory environment, including oversight of toxicology assay development, validation, quality systems, and regulatory compliance, required.
Eligible for a Certificate of Qualification issued by the NYS DOH confirming all expectations for CLIA directorship have been met, required

Knowledge, Skills, and Abilities:

Ability to quickly and accurately handle incoming test flow processes
Data entry skills via a keyboard (alpha and numeric) required
Strong eye-hand coordination
Able to handle a high volume environment while maintaining the highest level of quality
Ability to direct the activities of various levels of lab personnel
Ability to present and explain complex analytical information to non-technical audiences
Knowledge of general lab operations
Must be competent in all assigned functions to independently perform the duties and responsibilities of the area
Must be proficient in major functions of the lab

Physical Requirements:

Light to moderate physical effort (lift/carry up to 25 lbs.) -Heavier weights with assistance
Sitting & standing for long periods of time
Repetitive motions and/or prolonged computer use
Working at a fast pace, subject to many interruptions and both physical and mental stress

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