QA Specialist II

SGS_JOB_3722

Scientific
 Texas
Quality
Capa
Gmp

Contract - 6 Months

A QA Specialist II (Quality Operations) ensures that manufacturing and related processes comply with regulatory and quality standards such as GMP and ISO. The role involves supporting production activities, reviewing documentation, overseeing compliance, and contributing to continuous improvement in a biopharmaceutical or life sciences environment.

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.

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