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Job Description
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 114,000 colleagues serve people in more than 160 countries.
Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html)
student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html)
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
The position of
Manager, Quality Assurance
is within our
Toxicology business
unit located in Gretna, LA . The Quality Manager is responsible for the implementation, maintenance, and continuous improvement of the laboratory Quality Management System, ensuring that laboratory testing is performed in compliance with all applicable regulations and certifications, including, but not limited to, CAP, SAMHSA, and CLIA.
The role requires a dynamic and self-motivated professional with a demonstrated ability to influence change. Mastery of data necessary to influence fact and risk-based decisions and to demonstrate measured outcomes is a key requirement of the role. This role will be instrumental in providing quality results to our clients.
What You'll Work On
Develop, implement, and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulations and Rapid Diagnostic policies.
Develop mechanisms to identify compliance gaps and facilitate remediation activities where necessary utilizing risk-based prioritization.
Regularly report on quality and regulatory performance, including trending and analysis of deviations and non-conformance, to inform laboratory quality objectives, priorities, and improvements.
Keep abreast of new or changing quality and regulatory practices and standards within the industry and coordinate development of or update laboratory compliance standards, guidelines and programs as appropriate.
Support or participate in internal, client and regulatory agency audits to ensure
compliance with certification requirements, laws, regulations, policies and procedures. Includes routine audit of laboratory departments for compliance with company quality policy and
procedure
and
CLIA, and
State
requirements
where applicable.
Carries out duties in compliance with established BU and AQR practices, policies, and processes and provides subject matter expertise to drive improvements and decisions relating to quality
management systems.
Leverages quality metrics to identify risks for the organization in order to direct and support development/implementation of policy, procedure, training, and other available tools for reducing identified risks.
Ensures laboratory licensure is maintained through periodic renewals, new applications, method submissions and managing the proficiency testing
program.
Direct and perform internal and external audits related to regulatory, accreditation agencies and business partners. Demonstrate ability to maintain excellent positive relationships with auditors or regulatory agencies.
Administer and manage the document control system, incident reporting system and personnel
documentation.
Ensure that Quality Control and Quality Assessment programs are established and maintained to identify failures in quality as they occur.
Assist with development, implementation and maintenance of effective departmental QA programs
and monitors.
Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness.
Review
alllaboratory
proceduresand
validation documentation for compliance following regulation and guidance.
Monthly patient test management responsibilities include randomly selecting specimens for review of all external and internal COC, specimen label and test data records associated with these specimens including specimen reports (Tox2 and web) to ensure proper handling of patient specimens and test
data.
Oversee and manage quality system related meetings, collect and trend key performance indicators.
Review, report and action key quality metrics on routine basis including, but not limited to, Problem Specimens Log, Percent Positive Report, Audit Reports, CAPA and Nonconformance
data, etc.
Investigate unanticipated incidents that deviate from documented laboratory processes via the occurrence reporting system. Initiate CAPAs, as appropriate, to address system deficiencies and drive implementation of corrective action plans.
Address quality concerns raised by customers or identified
internally.
Request and maintain all vendor documentation.
Demonstrates commitment to thedevelopment, implementation
andeffectiveness
of Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and
testing activities
Required Qualifications
BA/BS Degree in Chemistry, Biology/Medical Technology or other related field
7 years in a toxicology laboratory setting, including 3 years in a Quality/Regulatory environment
Experience developing Lab Quality Management Systems and managing lab audits
Knowledge of 1988 Clinical Laboratory Amendments (CLIA '88) - federal certification requirements and State, Federal Accrediting Agency standards.
Experience as a people manager
Work
in a cross-functional environment, achieving regulatory compliance though teamwork, facilitation and influence .
Ability to
interpret regulatory agency requirements and to converting these into practical and pragmatic actions.
Strong written and verbal communication skills, including ability to articulate complex regulatory/quality arguments.
Organized and attentive to detail, strong interpersonal skills and capable of providing support and direction to others.
Preferred Qualifications
Professional certification
is preferred
(i.e. CQA, Six Sigma, CQM)
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
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.
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.
Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews.
The base pay for this position is $97,300.00 - $194,700.00. In specific locations, the pay range may vary from the range posted.
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
Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html)
student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html)
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
The position of
Manager, Quality Assurance
is within our
Toxicology business
unit located in Gretna, LA . The Quality Manager is responsible for the implementation, maintenance, and continuous improvement of the laboratory Quality Management System, ensuring that laboratory testing is performed in compliance with all applicable regulations and certifications, including, but not limited to, CAP, SAMHSA, and CLIA.
The role requires a dynamic and self-motivated professional with a demonstrated ability to influence change. Mastery of data necessary to influence fact and risk-based decisions and to demonstrate measured outcomes is a key requirement of the role. This role will be instrumental in providing quality results to our clients.
What You'll Work On
Develop, implement, and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulations and Rapid Diagnostic policies.
Develop mechanisms to identify compliance gaps and facilitate remediation activities where necessary utilizing risk-based prioritization.
Regularly report on quality and regulatory performance, including trending and analysis of deviations and non-conformance, to inform laboratory quality objectives, priorities, and improvements.
Keep abreast of new or changing quality and regulatory practices and standards within the industry and coordinate development of or update laboratory compliance standards, guidelines and programs as appropriate.
Support or participate in internal, client and regulatory agency audits to ensure
compliance with certification requirements, laws, regulations, policies and procedures. Includes routine audit of laboratory departments for compliance with company quality policy and
procedure
and
CLIA, and
State
requirements
where applicable.
Carries out duties in compliance with established BU and AQR practices, policies, and processes and provides subject matter expertise to drive improvements and decisions relating to quality
management systems.
Leverages quality metrics to identify risks for the organization in order to direct and support development/implementation of policy, procedure, training, and other available tools for reducing identified risks.
Ensures laboratory licensure is maintained through periodic renewals, new applications, method submissions and managing the proficiency testing
program.
Direct and perform internal and external audits related to regulatory, accreditation agencies and business partners. Demonstrate ability to maintain excellent positive relationships with auditors or regulatory agencies.
Administer and manage the document control system, incident reporting system and personnel
documentation.
Ensure that Quality Control and Quality Assessment programs are established and maintained to identify failures in quality as they occur.
Assist with development, implementation and maintenance of effective departmental QA programs
and monitors.
Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness.
Review
alllaboratory
proceduresand
validation documentation for compliance following regulation and guidance.
Monthly patient test management responsibilities include randomly selecting specimens for review of all external and internal COC, specimen label and test data records associated with these specimens including specimen reports (Tox2 and web) to ensure proper handling of patient specimens and test
data.
Oversee and manage quality system related meetings, collect and trend key performance indicators.
Review, report and action key quality metrics on routine basis including, but not limited to, Problem Specimens Log, Percent Positive Report, Audit Reports, CAPA and Nonconformance
data, etc.
Investigate unanticipated incidents that deviate from documented laboratory processes via the occurrence reporting system. Initiate CAPAs, as appropriate, to address system deficiencies and drive implementation of corrective action plans.
Address quality concerns raised by customers or identified
internally.
Request and maintain all vendor documentation.
Demonstrates commitment to thedevelopment, implementation
andeffectiveness
of Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and
testing activities
Required Qualifications
BA/BS Degree in Chemistry, Biology/Medical Technology or other related field
7 years in a toxicology laboratory setting, including 3 years in a Quality/Regulatory environment
Experience developing Lab Quality Management Systems and managing lab audits
Knowledge of 1988 Clinical Laboratory Amendments (CLIA '88) - federal certification requirements and State, Federal Accrediting Agency standards.
Experience as a people manager
Work
in a cross-functional environment, achieving regulatory compliance though teamwork, facilitation and influence .
Ability to
interpret regulatory agency requirements and to converting these into practical and pragmatic actions.
Strong written and verbal communication skills, including ability to articulate complex regulatory/quality arguments.
Organized and attentive to detail, strong interpersonal skills and capable of providing support and direction to others.
Preferred Qualifications
Professional certification
is preferred
(i.e. CQA, Six Sigma, CQM)
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
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.
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.
Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews.
The base pay for this position is $97,300.00 - $194,700.00. In specific locations, the pay range may vary from the range posted.
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
Key Skills Required
ManufacturingHTMLcontrol systemQuality ManagementAnalysisArticulateAssuranceAuditAwarenessBiologyCareer DevelopmentChemistryCommitmentCommunicationComplianceDemonstrated AbilityDesignDevelopmentDocument ControlDocumentationEffectivenessFacilitateGuidanceHealthcareImplementationIncident ReportingInfluenceInterpersonal SkillsLaboratory TestingLicensureMaintenanceManagementManagement SystemsPolicies and ProceduresPracticalPrioritizationProduct DesignProficiency TestingQuality AssessmentQuality AssuranceQuality ControlQuality Management SystemQuality MetricsQuality PolicyRegulationRegulatory ComplianceReimbursementRemediationReportingSecuritySix SigmaStrategyTeamworkTest ManagementToxicologyTrainingValidationVerbal CommunicationVerification and ValidationWritten and Verbal CommunicationInternational
Job Overview
Job Function: Other
Job Type: Full Time
Workplace Type: Not Specified
Experience Level: Not Specified
Salary: $97,300 - $194,700 / Annual Salary
Experience: 0 - 0 yrs
Contact Information
Company about us: Abbott is a global healthcare leader dedicated to improving the lives of people around the world. With a diverse portfolio of life-changing technologies, we are committed to helping people live healthier, fuller lives at every stage. Our company is driven by a strong mission to provide innovative solutions that address...
Company Name: Abbott
Recruiting People: HR Department
Website: https://www.abbott.com/
Headquarter: Abbott Park, IL, USA 60064-3500
Industry: Hospital / Healthcare
Company Size: 10000+ Employees
Location
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