QA Associate I
San Francisco Bay Area, CA Quality Assurance
Job Type
Full-time
Description

Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients. If you are up for a challenge, come join our team!


PBL has immediate openings for full or part time QA Associate I in the Quality Assurance Department. The QA Associate I will report to the Quality Manager or designated individual.  The general responsibility of the QA Associate I is to assist in activities related to maintenance of quality systems, documents and records, and activities associated with continuous improvement. Work must be performed in compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Quality System Regulations (QSR), ISO quality management system requirements, and other necessary regulatory requirements (e.g. OSHA, EPA, CDC, USDA, OLAW, etc.) as required by the task at hand, as well as any additional duties as assigned by Department Manager. 


PRIMARY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: 

  • Filing various types of studies
  • Laboratory Space Checks
  • Worksheet issuance
  • Maintenance and upgrades to eSOP system
  • Preparation, issuance, and maintenance of logbooks
  • GLP inspections
  • Intact scanning worksheet control forms
  • ISO proficiency testing support
  • Client and vendor audit scheduling, preparation, & hosting support
  • CAPA & Deviation maintenance
Requirements

 QUALIFICATIONS: 

  • High School Diploma or equivalent
  • Excellent organizational skills
  • Strong communication skills
  • Knowledge of pharmaceutical and/or medical device regulatory requirements expected (GLP, GMP, GCP) would be beneficial