ALMAC Group
Almac Group is currently seeking a Quality Systems Specialist for our Durham, NC location. The Quality Systems Specialist I will be responsible for ensuring compliance with CLIA/CAP, ISO15189, ISO13485, GCP, GLP and GCLP requirements within Almac Diagnostic Services. The role includes ensuring that Quality Management System activities are implemented and maintained. This includes document control, KPI reporting, LMS management, hosting audits, maintaining laboratory licenses/accreditations and QMS reviews to meet the company's quality policy and regulatory agencies.
Responsibilities
Ensure that Quality Helpdesk is maintained and document requests are managed in a timely manner.
Initial triage of incoming documents
Quality Systems review of documentation
Provide feedback to unit SMEs
Updating KPIs
System SME for business unit
Q-Track System Administration
Generate Weekly Q-Track KPI's
Advise Leadership on System Updates/Improvements
Generate Weekly SPC Chart and discuss trends with Team Leader/Manager
Trackwise (LMS) System and Reporting
System SME for Business Unit
Report Generation including KPI's
Provide Training
Maintain Laboratory Licenses and Accreditations Globally
Perform gap analysis against updated Standards and advise Management of required updates
Review calibration and maintenance data to confirm compliance with approved methods and procedures
Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel.
Including creating, reviewing, and approving policies, procedures, work instruction, protocols, and reports to ensure compliance with regulations including CLIA/CAP, ISO15189, ISO13485, GCP, GLP and GCLP
Making recommendations for improvements where appropriate
Qualifications
Required Experience / Education:
Bachelor's degree in biological or clinical laboratory science, or related field
Minimum of 1 year in a high complexity CLIA laboratory
Working knowledge of local, state, and federal laboratory regulations
Working knowledge of high throughput genomic technologies
Preferred Experience / Education:
Master's degree in biological or clinical laboratory science, or related field
Minimum of 3 years in a high complexity laboratory and additional experience working in an IVD environment
Minimum of 1 year managing Quality System activities across multiple quality system requirements, including operating CLIA/CAP, ISO15189, ISO13485, GCP, GLP and GCLP
Benefits
Medical, Vision & Dental benefits from the 1st of the month following start date
20 days PTO per year, accrued monthly following start date
12 holidays per year plus one day for Annual Diversity Day
Company paid Long and Short-term disability along with Life Insurance
401k company contribution
Professional development programs / continuous learning opportunities
Equal Opportunity Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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Responsibilities
Ensure that Quality Helpdesk is maintained and document requests are managed in a timely manner.
Initial triage of incoming documents
Quality Systems review of documentation
Provide feedback to unit SMEs
Updating KPIs
System SME for business unit
Q-Track System Administration
Generate Weekly Q-Track KPI's
Advise Leadership on System Updates/Improvements
Generate Weekly SPC Chart and discuss trends with Team Leader/Manager
Trackwise (LMS) System and Reporting
System SME for Business Unit
Report Generation including KPI's
Provide Training
Maintain Laboratory Licenses and Accreditations Globally
Perform gap analysis against updated Standards and advise Management of required updates
Review calibration and maintenance data to confirm compliance with approved methods and procedures
Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel.
Including creating, reviewing, and approving policies, procedures, work instruction, protocols, and reports to ensure compliance with regulations including CLIA/CAP, ISO15189, ISO13485, GCP, GLP and GCLP
Making recommendations for improvements where appropriate
Qualifications
Required Experience / Education:
Bachelor's degree in biological or clinical laboratory science, or related field
Minimum of 1 year in a high complexity CLIA laboratory
Working knowledge of local, state, and federal laboratory regulations
Working knowledge of high throughput genomic technologies
Preferred Experience / Education:
Master's degree in biological or clinical laboratory science, or related field
Minimum of 3 years in a high complexity laboratory and additional experience working in an IVD environment
Minimum of 1 year managing Quality System activities across multiple quality system requirements, including operating CLIA/CAP, ISO15189, ISO13485, GCP, GLP and GCLP
Benefits
Medical, Vision & Dental benefits from the 1st of the month following start date
20 days PTO per year, accrued monthly following start date
12 holidays per year plus one day for Annual Diversity Day
Company paid Long and Short-term disability along with Life Insurance
401k company contribution
Professional development programs / continuous learning opportunities
Equal Opportunity Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
EEO is the Law
EEO is the Law GINA Supplement
#J-18808-Ljbffr