Quality Assurance Specialist in Clinical Research

2 weeks ago

Richmond, Virginia, United States Clinical Research Partners, LLC Full time
Job Overview

The Quality Assurance Specialist (QAS) role is integral to the execution of Quality Assurance (QA) audit functions for designated studies, products, and vendors. This position is accountable for ensuring adherence to Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) standards, while also ensuring compliance with the company's Standard Operating Procedures (SOPs) and relevant regulations.


Key Responsibilities:

  • Conducts comprehensive QA audits, compiles audit reports, and communicates findings to relevant QA management and external stakeholders.
  • Engages in routine and directed audits of clinical sites, vendors, regulatory documentation, and marketing applications.
  • Acts as the primary QA contact, providing guidance for studies within specific Therapeutic Areas (TAs) or regions.
  • Participates actively in project teams, offering GCP compliance advice to enhance quality improvement initiatives.
  • Collaborates with stakeholders across regulatory, clinical, and development teams to deliver QA expertise.
  • Contributes to the formulation of QA strategies and supports quality objectives for assigned studies and regions.
  • Identifies and analyzes quality indicators to detect trends and risks, facilitating risk-based QA assessments.
  • Supports the development of clinical risk assessments and quality oversight initiatives in collaboration with the Quality Assurance Lead (QAL).
  • Conducts root cause analyses to promote knowledge-based auditing within respective TAs or regions.
  • Manages Significant Quality Issues for assigned studies, ensuring timely escalation of critical quality concerns.
  • Provides daily support to QA functional lines to ensure effective oversight of assigned studies.
  • Contributes to the enhancement of QA procedures and audit tools to maintain global consistency.
  • Assesses compliance of clinical investigator sites and study activities against ICH guidelines and company policies.
  • Delivers training sessions on GCP and PV topics, acting as a technical resource for GCP/PV issues.
  • Encourages standardization of auditing practices within the QA department.
  • Participates in special projects as assigned by QA management and mentors junior QA staff.


Education and Experience Requirements:

  • Bachelor's degree in a relevant field with a minimum of 8 years of experience in the pharmaceutical industry.


Preferred Qualifications:

  • Experience in GCP QA site audits.
Company Overview

This position is with Clinical Research Partners, LLC, a company dedicated to providing innovative solutions in clinical research. We focus on enhancing patient care through our state-of-the-art facilities and services.

  • Quality Assurance Specialist

    4 days ago

    Richmond, Virginia, United States Alfa Laval Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Alfa Laval. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key ResponsibilitiesPerform quality control measurements and inspections on finished products and components to...

  • Quality Assurance Specialist

    4 days ago

    Richmond, Virginia, United States Amcor Specialty Cartons Americas LLC Full time

    Job DescriptionJob Title: Quality Assurance SpecialistReports to: Senior Quality CoordinatorJob Summary: We are seeking a highly detail-oriented Quality Assurance Specialist to join our team at Amcor Specialty Cartons Americas LLC. As a Quality Assurance Specialist, you will be responsible for examining and testing printed products for defects and...

  • Quality Assurance Specialist

    2 days ago

    Richmond, Virginia, United States The LEGO Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at The LEGO Group. As a Quality Auditor, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesVerify the quality of products against LEGO standardsInvestigate and resolve quality issuesCollaborate with cross-functional teams...

  • Quality Assurance Specialist

    2 weeks ago

    Richmond, Virginia, United States InCharge Energy Full time

    InCharge Energy is in search of a meticulous Quality Assurance Specialist to evaluate new Electric Vehicle charging units, ensuring they are undamaged and operate effectively. The Quality Assurance Specialist will collaborate closely with the Pre-Commissioning Teams to guarantee that the output aligns with InCharge's stringent standards. This role reports...

  • Quality Assurance Specialist

    5 days ago

    Richmond, Virginia, United States Amcor plc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Amcor plc. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and maintaining our reputation for excellence.Key ResponsibilitiesExamine and test printed products for defects and nonconformance to verify product...

  • Quality Assurance Validation Specialist

    2 weeks ago

    Richmond, Virginia, United States Actalent Full time

    Position Title: Quality Assurance Validation SpecialistRole Overview: As a Quality Assurance Validation Specialist, you will collaborate closely with a network of manufacturing, development, and quality partners, ensuring that the organization’s interests in quality and compliance are upheld. You will be responsible for updating management on the status of...

  • Automation Quality Assurance Specialist

    7 days ago

    Richmond, Virginia, United States Triumph Full time

    Automation Quality Assurance Specialist Contract to Hire Onsite Daily Triumph is looking for an Automation Quality Assurance Specialist for an onsite role. In this position, you will play a key role in ensuring the quality and dependability of software applications through comprehensive testing and automation practices. You will work in close collaboration...

  • Senior Quality Assurance Automation Specialist

    2 weeks ago

    Richmond, Virginia, United States Apex Systems Full time

    Position: Senior Quality Assurance Automation SpecialistLocation: RemoteEmployment Type: Contract to Full-TimeCompensation: $60.00 / Hourly Rate (Dependent on experience)OverviewApex Systems is looking for a dedicated Senior Quality Assurance Automation Specialist to join our team. This role involves providing technical leadership and quality oversight to...

  • Automation Quality Assurance Specialist

    7 days ago

    Richmond, Virginia, United States Triumph Full time

    Automation Quality Assurance Specialist Contract to Hire Onsite Daily Triumph is in search of an Automation Quality Assurance Specialist for an onsite role. In this position, you will play a pivotal role in guaranteeing the quality and dependability of software applications through proficient testing and automation techniques. You will work in close...

  • Quality Assurance Senior Manager

    2 weeks ago

    Richmond, Virginia, United States DSJ Global Full time

    Job OverviewPosition: Quality Assurance Senior Manager - Consumer GoodsLocation: Richmond, VirginiaWork Arrangement: HybridExperience Level: Mid-Senior LevelWe are in search of a proactive Quality Assurance Senior Manager to become part of a prominent consumer goods organization that focuses on personal care items. Our mission is to provide exceptional...

  • Clinical Research Support Specialist

    2 weeks ago

    Richmond, Virginia, United States Commonwealth of Virginia Full time

    About the Organization:The Commonwealth of Virginia is dedicated to advancing healthcare through research and education, fostering an environment that promotes innovative solutions in medical science.As a prominent institution, it is recognized for its commitment to exceptional patient care and research initiatives.All full-time staff members benefit from a...

  • Software Quality Assurance Specialist

    5 days ago

    Richmond, Virginia, United States blueStone Staffing Solutions Full time

    Job SummaryWe are seeking a highly skilled Software Quality Assurance Specialist to join our team at blueStone Staffing Solutions. As a key member of our QA team, you will be responsible for ensuring the quality and reliability of our software products.Key Responsibilities:Quality Assurance: Actively participate in the quality assurance process, contributing...

  • Licensed Clinical Research Specialist

    2 weeks ago

    Richmond, Virginia, United States Commonwealth of Virginia Full time

    Commonwealth of Virginia - Licensed Clinical Research Specialist PositionBecome a vital part of the Commonwealth of Virginia's healthcare research team. Our organization is dedicated to advancing medical knowledge and improving patient outcomes through rigorous clinical studies.We offer a comprehensive benefits package for our full-time staff, which includes...

  • Senior Quality Assurance Automation Specialist

    2 weeks ago

    Richmond, Virginia, United States Apex Systems Full time

    Position: Senior Quality Assurance Automation SpecialistLocation: Flexible Work EnvironmentEmployment Type: Contract to PermanentCompensation: $60.00 / Hourly Rate (Dependent on experience)OverviewApex Systems is actively seeking a Senior Quality Assurance Automation Specialist to join our esteemed government client. This role is pivotal in providing...

  • Organ Procurement Quality Assurance Specialist

    2 weeks ago

    Richmond, Virginia, United States LifeNet Health Full time

    Position Overview As an Organ Procurement Quality Assurance Specialist, you will play a crucial role in ensuring compliance with industry regulations and standards. Location: Richmond, VA Department: Transplant Services Administration Employment Type: Full-Time Clinical Status: Non-Clinical Work Schedule: Monday to Friday, 8:15 AM...

  • Quality Assurance Automation Specialist

    2 weeks ago

    Richmond, Virginia, United States H & R COMPUTER CONSULTING SERVICES Full time

    Job OverviewPosition: Quality Assurance Automation SpecialistCompany: H & R COMPUTER CONSULTING SERVICESRole Summary:We are seeking a proficient Quality Assurance Automation Specialist to become a vital part of our innovative QA team. The successful candidate will take charge of designing, developing, and executing automated testing scripts to guarantee the...

  • Quality Assurance Automation Specialist

    2 weeks ago

    Richmond, Virginia, United States TekWissen ® Full time

    Position: Automation SpecialistLocation: Richmond, VAEmployment Type: ContractWork Arrangement: OnsiteContract Duration: 4+ MonthsCompensation: $45 per hourRole Overview:The Automation Specialist will be responsible for developing and implementing automated testing solutions to ensure the quality and reliability of software applications. The ideal candidate...

  • Food Quality Assurance Specialist

    2 weeks ago

    Richmond, Virginia, United States Sabra Dipping Company Full time

    Sabra Dipping Company is a leading name in the production of hummus and plant-based dips, dedicated to delivering sustainable and high-quality food options. With a legacy that began in 1986, the company is headquartered in New York and is committed to excellence in quality and environmental responsibility.We are currently looking for a Food Quality Assurance...

  • Clinical Trials Coordinator

    1 week ago

    Richmond, Virginia, United States Clinical Research Partners, LLC Full time

    Job OverviewPosition SummaryThe Clinical Trials Coordinator plays a vital role in the management and execution of clinical research projects under the guidance of the Principal Investigator and the Lead Clinical Research Coordinator.Key ResponsibilitiesFulfill necessary training requirements, including IATA/HAZMAT, sponsor-specific training modules, GCP, and...

  • Infrastructure Quality Assurance Specialist

    5 days ago

    Richmond Heights, Virginia, United States Henrico County Virginia Full time

    Job SummaryThe Henrico County Virginia is seeking a skilled Infrastructure Quality Assurance Specialist to join our team. As a key member of our construction division, you will be responsible for ensuring the quality and compliance of our infrastructure projects.Key ResponsibilitiesConduct regular site inspections to verify compliance with plans and...