GCLP Quality Assurance Specialist

3 weeks ago

Bethesda, United States Axle Full time
Job DescriptionJob DescriptionAxle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented GCLP Quality Assurance Specialist join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP)

Responsibilities
  • Develop and implement quality control reporting systems.
  • Serve as the subject matter expert for GCLP and GLP compliance-related inquiries from both internal and external stakeholders.
  • Perform internal inspections to ensure compliance with GCLP standards on a regular (e.g. during testing, monthly, or quarterly basis as required).
  • Provide assistance in the SOP management.
  • Maintain all master document inventories, program schedules, training files, word documents, and drafts with the Federal Task Leader and relevant GCLP staff.
  • Perform or delegate laboratory equipment control documentation and schedule necessary/routine preventative maintenance.
  • Review study documentation with management to ensure completeness and ensure proper archival of trial-related materials.
  • Maintain archives with proper disposal of documents according to record retention guidelines.
  • Prepare appropriate documentation and respond to requests for GCLP inspections and internal/external audits.
  • Provide support to management in preparing, tracking, and responding to deviations and CAPA.
  • Provide guidance and recommendations for development and improvement of the quality assurance and archival programs.
  • Adjust quickly to changes in schedule as priorities shift.
  • Wear appropriate Personal Protective Equipment (PPE) when in BSL-2 laboratories.
  • Work collaboratively with team members to ensure necessary information is cataloged, digitized, and archived at the end of a study.
  • Sustain close and effective communications with VIP management and external collaborators.

Experience Required / Requirements
  • BS with 5+ years of experience in a GCLP environment, working with quality assurance.
  • IT skills such that candidate knows or can quickly learn to utilize LIMS, CQMS, ELN, Microsoft Office, etc.
  • Ability to work well with others and independently.

Benefits
  • 100% Medical, Dental & Vision premium coverage for Employees
  • Paid Time Off (Including Holidays)
  • Employee Referral Bonus
  • 401K Match
  • Tuition reimbursement and professional development opportunities
  • Flexible Spending Accounts:
    • Healthcare (FSA)
    • Parking Reimbursement Account (PRK)
    • Dependent Care Assistant Program (DCAP)
    • Transportation Reimbursement Account (TRN)

The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact:
careers@axleinfo.com

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual's assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

  • Software Quality Assurance Engineer

    2 weeks ago

    Bethesda, United States agencyQ Full time

    Overview At agencyQ, our team members partner with our clients to develop digital solutions driven by our knowledge and strategic expertise. We are searching for an insightful and passionate Software Quality Assurance Engineer to join our team in Washington DC. The primary function of this Software QA Engineer will be to maintain and help guide overall...

  • Software Quality Assurance Engineer

    4 days ago

    Bethesda, United States agencyQ Full time

    Overview At agencyQ, our team members partner with our clients to develop digital solutions driven by our knowledge and strategic expertise. We are searching for an insightful and passionate Software Quality Assurance Engineer to join our team in Washington DC. The primary function of this Software QA Engineer will be to maintain and help guide overall...

  • Software Quality Assurance Engineer

    2 weeks ago

    Bethesda, United States agencyQ Full time

    Job DescriptionJob DescriptionSalary: Overview At agencyQ, our team members partner with our clients to develop digital solutions driven by our knowledge and strategic expertise. We are searching for an insightful and passionate Software Quality Assurance Engineer to join our team in Washington DC.  The primary function of this Software QA Engineer will...

  • it specialist

    1 month ago

    Bethesda, Maryland, United States Department Of Health And Human Services Full time

    Summary This position is located in the Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight (CCIIO), MITG, DMID.As an IT Specialist (Technical Advisor), GS , you will serve as a technical authority for the design, development and engineering of IT applications...

  • Biologist

    2 days ago

    Bethesda, United States RJ IT Solutions Full time

    RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...

  • Biologist

    7 days ago

    Bethesda, United States RJ IT Solutions Full time

    RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...

  • Research and Evaluation Specialist

    2 weeks ago

    Bethesda, United States Links Global Full time

    Links Global seeks a highly motivated and detail-oriented Research and Evaluation Specialist to join our team. The successful candidate will be crucial in designing, implementing, and overseeing research projects and evaluation initiatives. The position requires strong analytical skills, the ability to synthesize complex data, and a commitment to producing...

  • Research and Evaluation Specialist

    1 month ago

    Bethesda, United States Links Global Full time

    Job DescriptionJob DescriptionLinks Global seeks a highly motivated and detail-oriented Research and Evaluation Specialist to join our team. The successful candidate will be crucial in designing, implementing, and overseeing research projects and evaluation initiatives. The position requires strong analytical skills, the ability to synthesize complex data,...

  • Quality Control Manager

    18 hours ago

    Bethesda, United States Integrity National Corporation Full time

    Job DescriptionJob DescriptionThis is a general job description of a position at Integrity National Corporation (INC) that is open for submission of resumes. The following summary is intended to describe the general nature and level of work performed. The statements below are not intended to be construed as an exhaustive list of responsibilities, knowledge,...

  • Specialist-Guest Experience

    5 days ago

    Bethesda, United States Marriott International Full time

    Job Number 23224158 Job Category Rooms & Guest Services Operations Location Residence Inn Bethesda Downtown, 7335 Wisconsin Avenue, Bethesda, Maryland, United States VIEW ON MAP Schedule Part-Time Located Remotely? N Relocation? N Position Type Non-Management POSITION SUMMARY Our jobs aren't just about giving guests a smooth check-in and check-out....

  • Health Insurance Specialist

    3 weeks ago

    Bethesda, United States Centers for Medicare & Medicaid Services Full time

    Summary This position is located in (HHS), (CMS), Center for Consumer Information and Insurance Oversight (CCIIO). As a Health Insurance Specialist (Data and Analytics), GS-0107-13, you will apply a wide range of qualitative and/or quantitative methods for the assessment of the effectiveness of agency programs such as conducting program related...

  • Health Insurance Specialist

    3 weeks ago

    Bethesda, United States Centers for Medicare & Medicaid Services Full time

    Summary This position is located in the Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight (CCIIO). As a Health Insurance Specialist (Program Policy), GS-0107-13, you will apply a wide range of qualitative and/or quantitative methods for the assessment of...

  • Talent Acquisition Specialist

    1 week ago

    Bethesda, United States Eagle Creek Renewable Energy LLC Full time

    Job DescriptionJob DescriptionJob Title: Talent Acquisition SpecialistClassification: ExemptLocation: Bethesda, MD (hybrid)About the role: The Talent Acquisition Specialist will play a critical role in the planning, development, and execution of recruiting strategies in order to attract, proactively build, and maintain a quality talent pipeline. This...

  • Information Technology Specialist

    1 month ago

    Bethesda, United States Links Global Full time

    Job DescriptionJob DescriptionJob SummaryLinks Global seeks a skilled and customer-focused Information Technology Support Specialist to join our dynamic IT team. The ideal candidate will provide technical assistance and support related to computer systems, hardware, and software. The IT Support Specialist will diagnose and resolve technical issues, ensure...

  • Reports and Communication Specialist

    1 day ago

    Bethesda, United States Diverse Systems Group LLC Full time

    Job DescriptionJob DescriptionDescription:Overview:The Reports and Communication Specialist is responsible for overseeing the creation, dissemination, and management of reports and communications related to disaster response and recovery efforts. They play a critical role in ensuring timely and accurate reporting, as well as effective communication with...

  • Reports and Communication Specialist

    1 day ago

    Bethesda, United States Diverse Systems Group LLC Full time

    Job DescriptionJob DescriptionDescription:Overview:The Reports and Communication Specialist is responsible for overseeing the creation, dissemination, and management of reports and communications related to disaster response and recovery efforts. They play a critical role in ensuring timely and accurate reporting, as well as effective communication with...

  • Digital Marketing Specialist

    1 week ago

    Bethesda, Maryland, United States Employee Navigator Full time

    About Employee NavigatorEmployee Navigator is a rapidly growing and highly profitable $100M ARR SaaS insurance & HR technology company that works with the nation's leading insurance carriers, payroll companies & insurance brokers. Our products are designed to make it easier for our customers to manage the complexity of employee benefits & HR including...

  • Digital Marketing Specialist

    6 days ago

    Bethesda, United States Employee Navigator Full time

    About Employee Navigator Employee Navigator is a rapidly growing and highly profitable $100M ARR SaaS insurance & HR technology company that works with the nation’s leading insurance carriers, payroll companies & insurance brokers. Our products are designed to make it easier for our customers to manage the complexity of employee benefits & HR including...

  • Senior Conference Services Specialist

    1 week ago

    Bethesda, United States National Capitol Contracting LLC Full time

    Job DescriptionJob DescriptionPosition SummaryThis position is on-site in Bethesda, MD.National Capitol Contracting (NCC) is seeking an energetic, exceptionally organized Senior Conference Services Specialist to join our dynamic team of professionals on a full-time basis to support the NIH, the nation’s premier medical research and training...

  • Senior Conference Services Specialist

    2 days ago

    Bethesda, United States National Capitol Contracting LLC Full time

    Job DescriptionJob DescriptionPosition SummaryThis position is on-site in Bethesda, MD.National Capitol Contracting (NCC) is seeking an energetic, exceptionally organized Senior Conference Services Specialist to join our dynamic team of professionals on a full-time basis to support the NIH, the nation’s premier medical research and training...