3/17/15 – QA Associate

Accentuate Staffing is currently looking for a Quality Assurance Associate to work with our client in RTP.  The Quality Assurance Associate shall support the Company’s quality management system with a focus on continuous improvement and compliance with cGMPs, GLPs, FDA requirements, and internal SOPs.

Responsibilities

  • Review, maintain, and approve GXP (GLP, GMP and GCP) documentation including but not limited to analytical and bioanalytical test records, study reports, batch records, specifications, training records, and logbooks.  Create, review, and revise standard operating procedures
  • Administer the company training database. Issue controlled documents (batch records, logbooks, controlled forms, and lab notebooks).  Archive GXP records
  • Administer the equipment qualification status database. Assess the qualification status of equipment and instruments including review of qualification and calibration protocols and reports, and updating of status records
  • Participate in internal and external quality audits as required and communicate any significant findings to management
  • Exercise sound, decision making by providing guidance to departments and project teams regarding manufacturing, testing, storage and shipping, and other appropriate quality practices

The following duties apply to the conduct of GLP Studies:

  • Ensure quality assurance inspection coverage for the part of the study conducted on-site
  • Issue QA Statement to reflect inspection dates and the acceptability of the study performed on-site
  • Report any inspection results promptly in writing to the Principal Investigator, Management, the Study Director, Test Facility Management, and Test Facility QA
  • Maintain a copy of the Master Schedule
  • Maintain the approved study protocol/study plan and all study protocol amendments

Requirements

  • Bachelor’s Degree in biology, chemistry, microbiology, or related science.  Individuals with equivalent combination of education, training, and related experience will be considered
  • Typically 3+ years of pharmaceutical or related work experience in quality assurance, including early stage pharmaceutical development, GMPs, GLPs and GCPs.  Experience in a cGMP-compliant work environment is essential
  • Experience in managing, developing, organizing, and maintaining procedures, protocols, and quality records, is required