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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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