
Job Information
Abbott Site Director/Responsible Person , Gretna Laboratory in Gretna, Louisiana
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott Rapid Diagnostics (formerly Alere ) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Laboratory Director is within Toxicology located at Gretna, LA at Alere Toxicology Services. The primary function of the Laboratory Director is to establish and monitor the scientific procedures of the laboratory and to ensure compliance with the various protocols set forth by the applicable regulatory bodies that have jurisdiction over laboratory testing at Alere Toxicology Services, Inc. The laboratory is currently certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), Clinical Laboratory Improvement Act (CLIA), the College of American Pathologists – Forensic Urine Drug Testing (CAP-FUDT), and the States of Oklahoma, Maine, Pennsylvania, New York, Maryland, Florida, Vermont and Hawaii.
RESPONSIBILITIES:
Coordinate technical issues very closely with the Vice President, U.S. Laboratories, Toxicology, so there are no delays or disruptions caused by lack of coordination
Policy, Procedure, and Protocol Development and Review
Prepare, issue and interpret technical reports
Establish standard operating procedures and protocols to ensure the accurate and efficient testing of samples
Review, edit, and approve all laboratory procedure manuals, maintenance manuals, procedures, QA/QC procedures and records, and other documents as required, assuring that changes have been implemented and training is documented
Implement training programs to assure that all department personnel thoroughly understand and strictly adhere to established protocols and procedures
Regulatory Compliance
Assure compliance with DOT requirements on all DOT tests
Keep all protocols in compliance with SAMHSA and state certifying requirements
Comply with all certifying body orders and requests
Advise the COO of the effect of any regulatory changes and certification requirements
Act as Certifying Scientist for federal and non-federal results (Required to fulfill criteria of RP for SAMHSA).
Efficiency Management
Continually review procedures and protocols to improve turnaround, lower costs, and improve the quality of the Company’s testing services
Stay abreast of technology and developments relative to laboratory practices and procedures
Periodically review laboratory costs and implement internal action to reduce costs
Direct and assist in research and development
Oversee new project development and management
Assist the IT Department in the development and maintenance of the laboratory computer program
Quality Assurance and Control
Develop and maintain Alere Toxicology Services, Inc. quality assurance programs
Account for completion of all PT samples and responding to all agencies on any discrepancy concerning PT samples and/or inspections
Monitor QNQC results for laboratory data
Head the Quality Improvement Committee
Instrument Maintenance
Assure proper calibration of all instruments
Keep the laboratory’s instrumentation, equipment and laboratories in satisfactory conditions
Develop and maintain record keeping systems for the maintenance and calibration of all laboratory instruments
External Communications
Assure the Company is represented at seminars, industry meetings, and other appropriate technical forums
Foster and maintain good MRO and client relations, working closely with operations as appropriate
Publishes in conjunction with the Company
Provide legal testimony for laboratory findings and act as an expert witness when required
Desired Results
Acceptable rating on all inspections required by the regulatory bodies and certifying agencies
Implement training programs to assure that all applicable department personnel thoroughly understand and strictly adhere to established laboratory procedures
Act as a Certifying Scientist for regulated and non-regulated results
Provide result interpretation for clients
Represent the Company at seminars, industry meetings, and other appropriate technical forums
Must be able to testify in court to drug test results generated in the lab; when needed
Adhere to all security procedures for ensuring confidentiality of donor information
Must company with company policies
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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