Compliance Specialist, Analytical Development
Company: West Coast Consulting
Location: Newark
Posted on: April 1, 2026
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Job Description:
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
Keywords: West Coast Consulting, Milford , Compliance Specialist, Analytical Development, Science, Research & Development , Newark, Connecticut
