Compliance Specialist, Analytical Development

Newark, CA, US • Posted 2 days ago • Updated 20 hours ago
Contract W2
On-site
USD $53.00 - 54.39 per hour
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Biology
  • Chemistry
  • Pharmaceutics
  • Quality Assurance
  • GMP
  • Regulatory Compliance
  • Documentation
  • Quality Control
  • Crystal Management Console
  • Management
  • Testing
  • Test Methods
  • Random Testing
  • Analytical Skill
  • Change Control

Summary

Job Description

Title: Compliance Specialist, Analytical Development

Location: Newark, CA 94560

Must Haves

Bachelor's in Biology/Chemistry + 4 years biotech/pharma experience
GMP / regulated environment experience (QC, QA, or Analytical Development)
Experience with compliance documentation (change control, deviations, SOPs, protocols, reports)

Requriement:

Experience working in a GMP-regulated lab and different types of compliance documentation
Reviewed analytical or QC data packages.

Job Responsibilities:
Work closely with the CMC team to manage and coordinate analytical activities
Manage early and/or late phase drug substance and drug product analytical activities at contract testing laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
Execute technical analytical methodologies to support development and validation of test methods.
Author and review raw data (e.g. stability data packages and ad hoc testing), analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
Assist in authoring and reviewing various regulatory submission and interaction documents
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: wesca004
  • Position Id: JOB-7009
  • Posted 2 days ago
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