Global QA Validation Specialist- REMOTE

Location: Remote
Department: Azzur Cleanrooms-On-Demand-Services LLC
Expected Salary Range: $90K- 110K

Job Description

Azzur COD is looking Global QA Validation Specialist. This position is expected to execute tasks in accordance with the ACoD Quality Management System, including but not limited to review and approval of validation documentation.
This is a full-time remote work position. However, travel may be required on an as-needed basis to
ACoD sites.

Essential Functions:

Provides Quality oversight of the Global Validation Program by maintaining the following primary tasks:
  •    Assist in developing, reviewing, and approval of Global Validation and Engineering policies, procedures, and templates.
  •   Collaborate with ACoD Site and Global cross-functional teams to implement global continuous improvement initiatives.
  •   Provide Quality support on new construction or related global engineering projects.
  •   Review and approve validation lifecycle documentation, including, but not limited to, Validation Project Plans, User Requirement Specifications, IQ/OQ/PQ Protocols, Validation Reports, Traceability Matrices, Risk Assessments, etc.
  •   Review, approve, and provide guidance on validation documentation related to Facilities, Utilities, Systems, and Equipment (FUSE) qualifications. Qualifications may include controlled temperature chambers, Biosafety Cabinets, Computerized Systems, Coldrooms, Cryostorage, Classified Cleanrooms, etc.
  •   Monitor requalification timelines to ensure global compliance. Compile appropriate metrics related to the validation program, including tracking requalification activities.

Required Work Experience:

         8 years of experience within a QA validation or validation function in a GMP environment
         Previous experience in site development and launch is highly preferred
         Previous experience in computerized system validation is highly preferred

Required Education:
       Bachelor’s degree or higher in engineering or science-related discipline (equivalent work experience relevant to the position may be considered)

Benefits

Fulltime Employment with Azzur can offer you the following:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

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