Job Details
Abbott
Senior Laboratory Manager
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 115,000 colleagues serve people in more than 160 countries.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the [Register to View] student debt program and [Register to View] education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
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 Senior Laboratory Manager is within our Toxicology division located at Gretna, LA at Alere Toxicology Services. In this role, the Senior Laboratory Manager 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 in Gretna. Currently, the laboratory is 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.
What You’ll Work On
Coordinate technical issues very closely with the Site Director and DVP so there are no delays or disruptions caused by lack of coordination.
Policy, Procedure, and Protocol Development and Review including preparing, 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.
Assure Regulatory Compliance with DOT requirements on all DOT tests and keep all protocols in compliance with SAMHSA and state certifying requirements.
Comply with all certifying body orders and requests.
Advise the DVP of the effect of any regulatory changes and certification requirements.
Act as Certifying Scientist for federal and non-federal results
Act as the Laboratory Director for CAP-FDT, NY, CLIA, and all applicable states
Act as an Alt-RP or RP for SAMHSA
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 lT Department in the development and maintenance of the laboratory computer program.
Develop and maintain Abbott’s 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 QC results for laboratory data.
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.
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.
Required Qualifications
Ph.D. or advanced degree in technical field
5 to 10 years laboratory experience in the commercial laboratory industry with urine drug screening
The performance of the Senior Laboratory Manager will be considered to have met the standards expected when the following are accomplished:
Acceptable rating on all inspections required by the regulatory bodies and certifying agencies.
Passing grades on all proficiency testing as required by either the certifying bodies or the company.
Timely and correct analysis of samples
Records are complete, correct, and orderly
Protocols, standard procedures, documentation, and records are up to company and certifying requirements.
The prompt handling of any special project that the DVP may assign from time to time.
COMPETENCIES:
Advanced ability to understand analytical techniques and procedures.
Advanced ability to understand laboratory instrumentation.
Advanced ability to understand certification requirements for SAMHSA, CAP (College of American Pathologists), CLIA and other relevant regulatory bodies.
Advanced ability to understand the function of a LIS (Laboratory Information System) and other laboratory computer
systems.
Advanced ability to communicate ideas.
Advanced ability to teach others.
Advanced ability to write technical procedures.
Ability to lift and/or move 50 pounds
Must have vision and hearing corrected to meet minimum acceptable norms
Excellent math and reasoning ability to develop and communicate laboratory procedures and reports
Ability to read and comprehend the SOP, Federal (49 CFR Part 40), and CAP-FDT guidelines
Ability to communicate with other employees and supervisors
Ability to provide input and recommendations on operations
Climate-controlled office and testing laboratory environment
May be potential exposure to toxic or hazardous materials
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: [Register to View]
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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