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Batch Review Expert

2 months ago

Reston, Virginia, United States Integrated Resources, Inc ( IRI ) Full time

Job Summary:

Integrated Resources, Inc. (IRI) is seeking a Quality Assurance Specialist to provide direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.

Key Responsibilities:

  • Collaborate with the IPT Quality Release Lead and Quality Review Team to ensure product/process quality and perform activities to ensure that batches are reviewed for any process errors, discrepancies, and documentation errors.
  • Develop and maintain knowledge of Client Quality SOPs, production SOPs, and SAP functions as required by Quality Specialists.
  • Stay up-to-date on cGMPs, the manufacturing process, and Client quality systems.
  • Review and approve batches destined for both domestic and international markets.
  • Contribute to the development and implementation of quality-related processes and procedures.
  • Participate in quality-related training and development programs.

Requirements:

  • Bachelor's degree in a scientific discipline or related field.
  • Minimum of four years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
  • Basic understanding of cGMPs and regulatory requirements as they apply to the pharmaceutical field or a related area.
  • Proficiency in Microsoft applications (such as MS Excel, MS Outlook, and/or MS Word).
  • Familiarity with vaccine and/or pharmaceutical processing.
  • Familiarity with batch review and batch production systems such as Client-X, MES, etc.