QA Associate - Contract

Location: Concord, California, United States
Salary: US$40 - US$45 per annum + competitive
Job Type: Contract
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Quality Specialist - Contract until July 31st

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.

Qualifications/Requirements/Skills:

  • Bachelor's degree or equivalent in a scientific discipline with a minimum of 5 years' experience in a pharmaceutical or medical device industry or Master's Degree with a minimum of 3 years' experience.
  • Experience in GMP or GLP operations.
  • Strong understanding of the FDA GMP regulations, Medical Device Directive, ICH Q7, ISO 13485.
  • Ability to exercise independent judgment.
  • Strong data review and technical writing skills.
  • Direct experience with auditing techniques and evidence development.
  • High-level understanding of scientific approach and analytical thinking of others.
  • Strong communication skills (encompasses verbal, written, interpersonal, listening).
  • Ability to influence others.
  • High level of attention to detail and accuracy; very observant in order to audit properly.
  • Flexible; ability to adapt to changing priorities.
  • Excellent time management skills (schedules, timelines, task prioritization).

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

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