• Green Key Resources
  • Jersey City , NJ
  • Scientific Research
  • Full-Time
  • 10 Bayside Terrace

Job Description

The Manager Clinical QA & Auditing will be responsible for:

  • Assisting in the development and updates of GCP Risk Assessments.
  • Assisting in the development and implementation of the annual QA-GCP audit plan using a risk-basedapproach.
  • Developing an audit agenda and communications (e.g., pre-audit document requests) with auditees for each assigned audit project.
  • Conducting audits and meeting the following requirements: Ensure timelines for completion of audits are met. Comply with all applicable SOPs, policies, global regulations, etc. Escalate audit issues/concerns to QA management. Produce audit reports and corrective action tables. Develop status reports which key metrics on audit progress. Issues applicable audit certificates. Management of corrective and preventive action tables, including verification of corrective actions and effectiveness checks. Maintain accurate and timely documentation of assigned QA activities.
  • Preparing with line functions and QA management in the development of corrective action plans.
  • Analyzing and reporting trends in audit findings, as requested.
  • Reviewing and assessing key metrics (i.e., quality of TMF structure, risks, time for project, etc.).
  • Participating in program and protocol team meetings as the QA Representative.
  • Maintaining knowledge on industry leading practices and current regulations surrounding GCP compliance.
  • Participating in regulatory inspection activities for sponsor and sites as assigned.
  • Other QA-GCP activities assigned
  • Reports to Director, Clinical Quality Assurance.
  • BA/BS degree within a scientific discipline
  • Qualifications

  • A minimum of 8 years in the Pharmaceutical/Biotechnology industry is required with at least 3 to 4 years of independent GCP auditing experience preferably in relation to sponsor, site, central lab and vendor audits required
  • Pre-Approval Inspection readiness audit experience required.
  • Experience in clinical operations and handling trial essential documents is required.
  • Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP guidelines.
  • Experience and Skills

  • Working independently to complete assigned tasks.
  • Solid written and verbal communication skills, analytical and problem solving skills.
  • Flexible, highly motivated, with strong organization skills and the ability to multitask.
  • Be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
  • GLP and/or GVP auditing experience is a plus.
  • Knowledge of GXPs is a plus.

  • Associated topics: assistant, intern, internship, lab support, laboratory, laboratory support, laboratory technician, quality, quality control, research associate

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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