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Quality Associate III
Ref No.: 17-25398
Location: Herndon, California
  
Job Title: Quality Associate III
Location: One Baxter Way, Suite 100, Westlake Village, CA 91362
Duration: 12 Months
 
Description:
Position is responsible for quality system execution in support of drug, medical device, and combination products regulations and ISO Quality Standards.
 
Note: Location of position will transition from Westlake Village, CA to Thousand Oaks, CA in Q1, 2018.
 
ESSENTIAL DUTIES AND 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.
  • Assesses product quality performance to demonstrate levels of control, capability and compliance
 
QUALIFICATIONS
  1. Extensive experience authoring Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions in accordance with Common Technical Document (CTD) guidelines
  2. Thorough working knowledge of FDA 21 CFR parts 4, 210, 211, 820, and ISO 13485
  3. Experience with quality tools and process improvement techniques
  4. Strong interpersonal skills and attention to detail
  5. Strong team player with good problem solving and verbal / written communication skills.
  6. Must be able to handle multiple projects concurrently.
  7. Ability to quickly master usage of quality management system software
 
EDUCATION AND/OR EXPERIENCE
  1. BS in engineering/science or equivalent.
  2. 5-8 years' experience in Quality within a pharmaceutical or medical device company.