Quality Assurance Specialist

1 month ago


Montgomery County, United States Department Of Health And Human Services Full time
Summary

The Quality Unit within the CCE is responsible for ensuring the safety, quality, purity, potency, and effectiveness of all services and activities in the CCE and for ensuring the reliability of services and data is in accordance with accrediting and regulatory agency requirements including NIH, USP, FDA, and TJC. The incumbent serves as a Quality Assurance Specialist (Hematopoietic) responsible for the Quality Assessment/Improvement (QA/I) program for hematopoietic stem cells in the CCE.



Duties

As a GS-1910-12 Quality Assurance Specialist (Hematopoietic Stem Cell Therapy), your duties may include but are not limited to the following:

  • Administering the hematopoietic stem cell quality program in the CCE including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency.
  • Ensuring that CCE activities are in compliance with AABB (Association for the Advancement of Blood and Biotherapies), Federal Drug Administration (FDA), and other standards related to the processing, storage, and infusion of hematopoietic stem cells.
  • Serving as the primary CCE point of contact for accreditation applications and inspections with the AABB, other accrediting organizations or entities for off-site manufacturing protocols.
  • Coordinating activities related to inspections and audits of the CCE by the AABB, other accrediting organizations, or entities for off-site manufacturing protocols.
  • Ensuring patient reactions related directly to the infusion of hematopoietic stem cell products, cell therapies, and gene therapies are appropriately documented and appropriately reported.



  • Montgomery, United States Zing Recruiting Full time

    Job DescriptionJob DescriptionSpecialist - Quality AssuranceIndustry-Leading Benefits:- Competitive wages and bonus potential- Generous paid time off, holidays, and vacation days- 93% Company-paid Medical, Dental, and Vision for Team Members and their families from day one- 401(k) savings plan with immediate company matching- Discounts on new Hyundai...


  • New Hanover County, NC, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate - Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study tables...


  • New Hanover County, NC, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate – Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study...


  • New Hanover County Airport, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate – Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study...


  • Montgomery, United States Zing Recruiting Full time

    Job DescriptionJob DescriptionWe believe in your limitless potential. From roles in quality control and maintenance to finance, human resources, and team relations, your career possibilities are boundless.Why Apply?Joining our team comes with a range of benefits, including:- Competitive wages and bonus potential- 15 paid holidays, 3 personal days, and 10...


  • Montgomery, United States MS Companies Full time

    MS Companies has an Automotive Assembly Plant Quality Assurance Auditor opportunity. This is a direct hire position with a world class OEM. Must have US Citizenship or Permenant Resident status to qualify - No VISAs.Position Summary:Responsible for proactively analyzing claim data to track and monitor all issues and to assign any suspected issues to proper...


  • Montgomery, United States MS Companies Full time

    MS Companies has an Automotive Assembly Plant Quality Assurance Auditor opportunity. This is a direct hire position with a world class OEM. Must have US Citizenship or Permenant Resident status to qualify - No VISAs.Position Summary:Responsible for proactively analyzing claim data to track and monitor all issues and to assign any suspected issues to proper...


  • Montgomery, United States Insight Global Full time

    Director of Quality AssuranceLocation: Montgomery, AL (offering relocation)Day to Day:Own and continually improve QMS/EMS driving enhanced and value added processes to support customer requirements, business needs, execution of company goalsDevelop measurable Quality improvement plans and data analysis methodsDrive Key Performance Metrics continually...


  • Montgomery, United States Insight Global Full time

    Director of Quality AssuranceLocation: Montgomery, AL (offering relocation)Day to Day:Own and continually improve QMS/EMS driving enhanced and value added processes to support customer requirements, business needs, execution of company goalsDevelop measurable Quality improvement plans and data analysis methodsDrive Key Performance Metrics continually...


  • Montgomery, United States Insight Global Full time

    Director of Quality Assurance Location: Montgomery, AL (offering relocation) Day to Day: Own and continually improve QMS/EMS driving enhanced and value added processes to support customer requirements, business needs, execution of company goals Develop measurable Quality improvement plans and data analysis methods Drive Key Performance Metrics continually...


  • Montgomery, United States Insight Global Full time

    Director of Quality AssuranceLocation: Montgomery, AL (offering relocation)Day to Day:Own and continually improve QMS/EMS driving enhanced and value added processes to support customer requirements, business needs, execution of company goalsDevelop measurable Quality improvement plans and data analysis methodsDrive Key Performance Metrics continually...


  • Montgomery, United States CEG Full time

    Position Summary:Responsible for proactively analyzing claim data to track and monitor all issues and to assign any suspected issues to proper teams to be investigated in an automotive manufacturing environment. This position involves continuous collaboration with responsible teams and affiliates to ensure plant's Safety-Quality standards are met by all...


  • Montgomery, United States CEG Full time

    Position Summary:Responsible for proactively analyzing claim data to track and monitor all issues and to assign any suspected issues to proper teams to be investigated in an automotive manufacturing environment. This position involves continuous collaboration with responsible teams and affiliates to ensure plant's Safety-Quality standards are met by all...


  • Montgomery, United States CEG Full time

    Position Summary:Responsible for proactively analyzing claim data to track and monitor all issues and to assign any suspected issues to proper teams to be investigated in an automotive manufacturing environment. This position involves continuous collaboration with responsible teams and affiliates to ensure plant's Safety-Quality standards are met by all...


  • Orange County, United States Bridgeview Solutions Full time

    Job DescriptionJob DescriptionBridgeview Solutions is leading a confidential search, on behalf of a well-known brand that bridges manufacturing and technology, to identify a Lead Quality Assurance Technician to oversee a high-performing QA team and bring technical expertise and a continuous improvement mindset to the organization's QA...


  • Montgomery, United States Tech Providers Inc. Full time

    Quality Assurance AnalystMontgomery AL (Onsite)12+ Months contract Must have skills: Automation Tester  Cypress JS LoadRunner Skills Required Manual Testing Automated Testing, including at least one industry standard automated testing tool Performance Testing, including at least one industry standard performance testing tool Test Script Development...


  • Montgomery, United States Tech Providers Full time

    Quality Assurance Analyst Montgomery AL (Onsite) 12+ Months contractMust have skills: Automation Tester Cypress JS LoadRunner Skills Required Manual Testing Automated Testing, including at least one industry standard automated testing tool Performance Testing, including at least one industry standard performance testing tool Test Script Development Test...


  • Montgomery, United States Tech Providers Full time

    Quality Assurance Analyst Montgomery AL (Onsite) 12+ Months contract Must have skills: Automation Tester  Cypress JS LoadRunner  Skills Required Manual Testing Automated Testing, including at least one industry standard automated testing tool Performance Testing, including at least one industry standard performance testing tool Test Script Development...


  • Montgomery, United States MS Companies Full time

    Job Title: Advanced Quality Improvement Specialist (Automotive OEM)aka Advanced Quality EngineerPosition Type: Direct-Hire# of Openings: 2 (See Group 1 & 2)Location: Montgomery, ALShift: 1st (6:30AM - 4:45PM) - 1.5x overtime after 40 hrs/weekSalary Range: $60k - $85kRelocation Provided Position Summary:Support Advanced Quality Improvement department goals...


  • Montgomery, United States MS Companies Full time

    Job Title: Advanced Quality Improvement Specialist (Automotive OEM)aka Advanced Quality EngineerPosition Type: Direct-Hire# of Openings: 2 (See Group 1 & 2)Location: Montgomery, ALShift: 1st (6:30AM - 4:45PM) - 1.5x overtime after 40 hrs/weekSalary Range: $60k - $85kRelocation Provided Position Summary:Support Advanced Quality Improvement department goals...