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Specialist QA, Biopharma Medical Device – Remote (JP9916)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Specialist QA, Biopharma Medical Device – Remote (JP9916)
Location: Thousand Oaks, CA. (100% Remote)
Employment Type:  Contract
Business Unit: Final Product Technologies Quality
Duration: Initial 6 months with likely extensions and/or conversion to permanent
Posting Date: 03/04/22
Rate: $30-33/Hr DOE

Notes: 100% remote. Can location but support PST time zone hours.  3 must haves are extremely important.  BA preferred.  3-5 YOE Quality experience.Subject to extension beyond 6 months


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 – Commercial Quality 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.

Why is the Position Open?
Backfill.

Top Must Have Skills:
  • Deviation/CAPA working knowledge.
  • Medical Device/Combination product experience.
  • Excel and other data analysis tools.
  • Detail oriented in documentation.
  • Good communication and interpersonal skills.

Day to Day Responsibilities:
  • Facilitating CAPA Board meeting.
  • Documenting meeting minutes.
  • Generating weekly/monthly metrics data related to Deviation/CAPA.
  • Owning Deviation/CAPA records.

Employee Value Proposition:
  • Remote jobs.
  • High visibility.
  • Gain Important quality management experience.

Red Flags:
  • No medical Device/Combination product.
  • No deviation/CAPA working experience.

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.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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