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