732-661-0400

Quality Auditor (Hybrid)

  • Location: Tewksbury, MA
  • Type: Direct Hire
  • Job #35926

Seeking a Quality Auditor for our client – the world leading producer of stable isotope compounds. You will be independently performing quality audits of their testing laboratories, contractors and suppliers that support the companies Active Pharmaceutical Ingredients (APIs) to ensure products, controls, procedures and processes meet quality standards. If you have experience LEADING internal and external quality audits in a GMP environment – apply today!

Responsibilities

  • Audits, across multiple sites, raw material manufacture, suppliers of API, excipients, packaging components, and firms providing GMP services such as laboratories and others as required.
  • Independently conducts internal and external audits, acting as Lead Auditor of an audit team, or as a participating audit team member where appropriate.
  • Able to perform high profile due diligence audit for corporate management.
  • Schedules audit activities and develop audit agenda.
  • Independently performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and Quality Standards (GMP, ICH, ISO, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
  • Prepares audit reports and communicates findings to external and internal stakeholders.
  • Tracks audit responses and auditee s CAPA until completion and closeout.
  • Performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
  • Prepares audit reports and communicates findings to internal stakeholders.
  • Tracks audit responses and auditee s CAPA until completion and closeout.
  • May provide document support for regulatory audits and mock inspections.
  • Leads and/or supports cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards.
  • Participates in the development of QA programs, policies, procedures and controls.

Requirements:

  • Minimum of a BS degree in Science or Pharmaceutical studies with a minimum of 5 years’ experience in a pharmaceutical manufacturing or Quality Assurance environment.
  • Knowledge of FDA regulations, GMP/GLP/GCP, ISO 9001, and other quality management systems
  • Possesses a technical and quality background related to the pharmaceutical or chemical industry.
  • Has thorough knowledge of current standards and regulations related to pharmaceutical forms/devices, (e. g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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