Quality Assurance Associate

Location: Concord, California Salary: US$30 - US$40 per hour + competitive
Sector: Technical and Quality Assurance Type: Contract

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP, GLP and ISO 13485 compliance support as necessary.

Primary Responsibilities:

  • Audit reports and raw data for compliance with protocols, SOPs and regulations, including design verification, stability, aging, sterilization, and validation.
  • Review manufacturing, QC, release records, and documentation for medical device and drug substance/drug product.
  • Oversee change control program, including review of change documentation, tracking activities, and verification of effective implementation.
  • Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
  • Identify compliance weaknesses and ensure the implementation of workable solutions.
  • Write/revise/review SOPs/INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
  • Perform other related duties as required.

Sthree US is acting as an Employment Business in relation to this vacancy.