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Specialist Quality Assurance –  REMOTE (JP9366)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Specialist Quality Assurance –  REMOTE (JP9366)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: Final Product Technologies Quality Commercial - Mechanical
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 10/27/2021

3 Key Consulting is hiring a Specialist Quality Assurance for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
As a member of client's Commercial Quality group for drug delivery systems, the QA Specialist will provide quality engineering support for the product life cycle management and design control systems in the maintenance of commercialized drug delivery devices, combination products, and non-combination products.  Responsibilities include:
  • Participation in the implementation of Design controls per FDA CFR 820.30, Corrective and Preventive action projects CFR 820.100, documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
  • Manages low to moderate complexity programs with minimal supervision.
  • Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases.
  • Participates in non-design control investigations on an as needed basis.
  • Must work in Pacific time zone

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:
  • Deviation/CAPA process and records working knowledge.
  • Experience with tools such as Trackwise, Teams, Smartsheet, Excel etc.
  • Medical device/Combination product experience.

Day to Day Responsibilities:
  • Owning/QA for Deviation/CAPA records.
  • Deviation Trend analysis.
  • Interim timepoint checks for CAPA/EV records.
  • Automating data analysis using tools.
  • Documentation.

Basic Qualifications:
  • BA preferred.
  • 3-5 YOE.
  • Nonconformance, Deviation, CAPA process experience.
  • Root cause analysis techniques.
  • Data analysis and familiarity with CAPA management tools.

Employee Value Proposition:
High visible role with interaction of multiple departments.

Red Flags:
Does not meet top 3 skills

Interview process:
Video Skype Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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