Compliance Specialist, Analytical Development

Company: West Coast Consulting
Location: Newark
Posted on: April 1, 2026

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, Bloomfield , Compliance Specialist, Analytical Development, Science, Research & Development , Newark, New Jersey