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QA Specialist II

SGS Consulting

Job Responsibilities:

  • Ensure compliance with GMP, ISO, and regulatory requirements across manufacturing operations
  • Review and approve GMP master documents and executed records (e.g., batch records, QC documents)
  • Support investigations, deviations, and CAPA (Corrective and Preventive Actions)
  • Perform QA walkthroughs and provide on-the-floor quality oversight
  • Collaborate with manufacturing, QC, and support teams to resolve quality issues
  • Review Master Batch Records (MBR) and supporting documents for batch disposition
  • Approve/release materials such as buffers and media when required
  • Track and maintain quality records and ensure proper documentation practices (GDP)
  • Support change control processes and validation-related activities
  • Identify compliance gaps and recommend improvements
  • Ensure adherence to safety and quality standards in all operations

Skills:

  • Strong knowledge of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)
  • Familiarity with ISO quality systems and global regulatory requirements (US/EU)
  • Experience in biopharmaceutical or biologics manufacturing environments
  • Understanding of CAPA, deviations, and change control processes
  • Knowledge of equipment, facilities, and utilities validation
  • Ability to review and interpret batch records and quality documentation
  • Proficiency in quality management systems (QMS)

Education/Experience:

  • Bachelors.
Vacancy posted 9 days ago
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