QA Specialist II

SGS Consulting; Austin (TX); Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

SGS Consulting in Austin, TX seeks a QA Specialist to ensure GMP/GDP compliance across manufacturing operations and review batch records.

You will support investigations, CAPA, deviations, and change controls while performing on-the-floor QA walkthroughs and collaborating with manufacturing, QC, and support teams.

This role emphasizes proper documentation practices, adherence to safety and quality standards, and continuous improvements in regulatory readiness.

Qualificações

• GMP/GDP knowledge required.
• Experience with quality management systems (QMS).
• Familiarity with CAPA, deviations, and change controls.

Responsabilidades

• 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.

Conhecimentos

GMP

GDP

QMS

CAPA

Deviation handling

Change control

Batch records review

Biopharma manufacturing

Formação académica

Bachelor's degree

Descrição da oferta de emprego

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.