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Clinical QA Consultant

REMOTE, CA 94080

Posted: 01/17/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 536585 Is job remote?: Yes Country: United States

Job Description

Job Description:
  • Ensure the quality and compliance of clinical activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
  • Prepare and conduct or assist/oversee contract auditors for GxP audits per established strategies
  • Audit, as required, and provide audit results to stakeholders and support process improvement activities asa subject matter expert (SME) in GCP/GPvP/GLP
  • Support the development of internal systems for the maintenance of internal audit files, Tracking Log and related Clinical QA outputs/summaries/metrics.
  • Establish contract agreements and Statement of Works (SOWs) with Clinical QA consultants, according to the internal process. with Legal input
  • Conduct/oversee Clinical QA review of draft protocols; Informed Consent Forms, aggregate safety reports, clinical study reports and other clinical trial specific documents, when requested
  • Conduct/oversee risk-based audits of service providers, internal systems and clinical investigators involved with clinical trial programs
  • Conduct/oversee of regulatory training for GCP/GPvP/GLP as needed
  • Conduct the review of clinical trial related SOPs
  • Support efforts to enhance and establish a corporate-wide Quality Management System (QMS)
  • Lead in the inspection readiness activities; attend clinical trial team meetings, provide Clinical QA advice, as necessary to clinical teams and functions
  • Maintain working knowledge of FDA, EU and other global regulations and guidance governing GCP/GPvP/GLP.
  • Maintain file organization within the Clinical Quality Assurance Department
  • Other duties as assigned

Skills:
  • Excellent understanding of Clinical Development Process
  • Experience writing and reviewing SOPs which support clinical trials•Good understanding of FDA GCP and ICH regulatory requirements and implementation
  • Good knowledge of Computer System Validation (CSV) in association with GCP/GPvP/GLP audits
  • Good knowledge of clinical laboratory requirements and method validation
  • Effective communication (verbal and written)
  • Strong interpersonal skills, team player, and flexible without compromising quality
  • Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
  • An ability to be productive and successful in an intense work environment
  • Experience with participating in global regulatory inspections

Education:
  • Minimum Bachelor’s degree in a healthcare or scientific-related discipline with 8 years for experience in GCP/GPvP/GLP quality assurance experience in a pharmaceuticals or biotechnology industry (an equivalent combination of experience and education may be considered)
Target Pay Rate Range: $90-$100/hr. Salary will be commensurate with experience 
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