Job Details

  • Title: QC Associate
  • Code: RCI-7135
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 03/24/2020
  • Duration: 12 Months
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  Job Description

Provides end-to-end program management and quality control support for the non-clinical sections of Regulatory submissions, while working in close partnership with stakeholders in Research and Global Regulatory Affairs. The prospective candidate for this position (QC Verification) will be expected to:

  • Perform data verification and quality check (QC) between electronic lab notebooks (ELN) and research study reports
  • Prepare and verify data integrity of scientific and regulatory documents (eg, study reports and ELNs)
  • Facilitate the completion of data integrity and QC processes
  • Ensure consistency and compliance with report writing and ELN documentation procedures
  • Conduct formal QC review and data verification of nonclinical research study reports and related ELNs, and other regulatory documents
  • Participate in the development and alignment of QC timelines for regulatory documents and preparation of assigned deliverables
  • May collaborate with external contractors and contracted research organization (CRO) vendors on QC related matters
  • Potential opportunity to serve as ICH Module 4 nonclinical study report coordinator (based upon performance and/or functional area need)
  • Strong attention to detail, including the ability to verify data/information, proofread and reformat documents
  • Excellent written/oral communication skills
  • Ability to be proactive and independently understand, follow, and implement Instructions
  • Able to manage multiple tasks at once and to work effectively with teams using strong interpersonal skills
  • Experience in reading, understanding, and applying scientific data integrity checks to nonclinical research study reports, final study reports, and/or contributing scientist reports, and other regulatory documents
  • Ability to effectively operate in an environment which requires collaboration, analytical judgment, and adherence to critical timelines
  • Fluent in MS Windows 7, MS Office, and Adobe Acrobat
  • Familiarity with working in data management systems
  • Time and project management skills
  • Knowledge of scientific/technical writing and editing
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Knowledge of GxP, ICH guidelines, eCTD format, drug development process, regulatory affairs, and regulatory compliance
  • Bachelor's Degree and 1 year of science- or quality compliance-related experience OR Associate degree and 3 years of science- or quality compliance-related experience
Preferred Qualifications:
  • Bachelor of Science degree
  • 3 or more years of experience within pharmaceutical, biotech or medical device industry