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GCP Quality Assurance Specialist

Cambridge, MA

Posted: 02/11/2021 Employment Type: Contract Job Category: Clinical: Quality Job Number: 2764

Job Description

Reporting to the Senior Manager of GCP QA, the GCP QA Specialist contractor will be responsible for supporting GCP QA activities and ensuring that all systems and processes are compliant with good clinical practice (GCP) guidelines, standards, and regulations (FDA, MHRA, EMA, ICH). Additional responsibilities include assisting GCP QA and Quality Systems with Training, Document Control, tracking GCP elements of the Quality Management System (QMS), logistical support for Inspection Readiness activities, Project and clinical trial support, and Vendor oversight, including audit support and audit closeout. This individual will also assist with continuous improvements of GCP quality processes and will support the state of GCP compliance to ensure high quality execution of clinical trials from first in human through commercial marketing authorization.

  • Assist in the development, implementation, and maintenance of GCP Quality Systems and SOPs
  • Participate in the execution of GCP QA strategies for the support of global clinical trials.
  • Provide support for internal and external audits related to studies, systems, documents and functions
  • Support conduct of audits, mock inspections and health authority inspections
  • Assist with preparations for GCP/PV inspections for corporate as well as CROs and investigator sites
  • Provide administrative support to the GCP QA representatives on clinical teams to ensure compliant execution of clinical studies
  • Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management
  • Ensure Clinical Development activities are compliant with GCP, GLP, FDA, ICH, EMA regulations and guidelines and industry standards
  • Participates in departmental compliance projects and process improvement initiatives, as requested

  • Minimum of 3 years of relevant experience in a biotech/pharmaceutical or healthcare setting, preferably with GCP Quality Assurance experience
  • Excellent interpersonal, organizational, verbal, and written communication skills, with the ability to work in a team environment
  • Working knowledge of relevant FDA, EU, ICH GCP guidelines and regulations
  • Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines
  • Experience in supporting Regulatory Authority GCP/PV Inspections
  • Continue to develop experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing
  • Has led or supported document review (source data verification) initiatives for example: DSUR, IB, NDA, CSR, etc., deploying both internal and external resources
  • Demonstrated ability to work independently and seek resources as necessary
  • Ability to foster effective relationships with vendors, investigators and colleagues
  • Proficiency in study monitoring activities
  • Knowledge of the infrastructure and operational characteristics of CROs and centralized services

Meet Your Recruiter

Tim Borop
Clinical Recruiter

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