Quality Systems Specialist

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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. In particular, to ensure that Quality Management System activities are implemented and maintained. This includes but not limited to document control, KPI reporting, LMS management, hosting audits, maintaining laboratory licenses/accreditations and QMS reviews are adequately planned, performed, and implemented on a continual basis as required by the company's quality policy and regulatory agencies.
 
Responsibilities include but are not limited to:
  • Ensure that Quality Helpdesk is maintained and document requests are managed in a timely manner.
    • This includes;
      • 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
    • This will include performing gap analysis against updated Standards and advising 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.
    • Includes 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 year 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.
What can Almac Group offer you?
  • 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 as well as 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
 
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry.  We are a privately owned organization that has organically grown over 50 years now employing over 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all.  Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
 
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
 
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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