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← Personalis, Inc

Sr. Document Control Specialist (Temp - 3 Month)

Personalis, Inc
Location
Fremont, CA
Posted
17 days ago
Department
Quality and Compliance
Salary
$39.00 to $44.00
What they actually want (must-haves)
  • Bachelor’s degree or equivalent experience in a document control capacity
  • 3+ years of experience in document control within a regulated medical device, IVD, or pharmaceutical environment
  • Hands-on experience with Electronic Document Management Systems (EDMS)
  • Sound working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements
  • High precision in proofreading, formatting, and verifying document compliance
  • Proven ability to work independently and prioritize competing tasks
Nice to have
  • Experience with ComplianceQuest (CQ)
What the job really is

The Sr. Document Control Specialist will be a vital member of the Quality Assurance team, overseeing document control operations within a regulated environment. Responsibilities include managing Document Change Orders (DCOs), collaborating with various departments to resolve discrepancies, maintaining quality records, facilitating periodic document reviews, and providing general QA support. This role requires a high degree of independence and attention to detail.

Things to weigh
  • This is a temporary position for 3 months.
  • The role operates in a regulated environment, which may involve strict compliance requirements.
  • No remote work is mentioned, indicating a need to be onsite in Fremont, CA.
Job score3.4/5
Benefits1/5
Freshness4/5
Career value3/5
Role clarity4/5
Pay transparency5/5

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