Quality Associate III in Westlake Village, CA at Apex Life Sciences

Date Posted: 2/1/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Quality Associate III to join an established team in the Thousand Oaks, CA area!

Description:

  • Position is responsible for quality system execution in support of drug, medical device, and combination products regulations and ISO Quality Standards. 

Responsibilities:

  • Authors and approves regulatory submissions, including initial applications, supplements, and annual reports for sterile water for injection (sWFI), delivery and transfer devices, and combination products. 
  • Manages timely completion of investigations, complaints, non-conformances, CAPAs, and change controls 
  • Interfaces with suppliers including authoring of quality agreements and participation in audits as lead auditor or SME 
  • Support / leads projects to develop and qualify sWFI for use in companyproducts 
  • Assesses product quality performance to demonstrate levels of control, capability and compliance 

Requirements:

  • BS in engineering/science or equivalent. 
  • 5-8 years’ experience in Quality within a pharmaceutical or medical device company.
  • Extensive experience authoring Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions in accordance with Common Technical Document (CTD) guidelines 
  • Thorough working knowledge of FDA 21 CFR parts 4, 210, 211, 820, and ISO 13485 
  • Experience with quality tools and process improvement techniques 
  • Strong interpersonal skills and attention to detail 
  • Strong team player with good problem solving and verbal / written communication skills. 
  • Must be able to handle multiple projects concurrently. 
  • Ability to quickly master usage of quality management system software