Quality Assurance Batch Record Specialist

2 weeks ago


Fremont, California, United States Astrix Full time

Company Overview:

Astrix is a leading global pharmaceutical organization dedicated to advancing treatment options for challenging diseases and conditions. We are currently seeking a skilled Batch Record Reviewer II to enhance our Quality Assurance team. This role presents a unique opportunity to contribute to innovative therapies and positively impact patient care.

Location: Not specified

Compensation: Competitive hourly rate

Position Summary:

The Batch Record Reviewer II operates autonomously to ensure quality assurance compliance across designated areas, adhering to current Good Manufacturing Practices (cGMPs) and Quality Control Systems. This position requires a high degree of independent judgment and the ability to swiftly identify, investigate, and resolve quality-related issues affecting products and processes.

Key Responsibilities:

  • Maintain compliance with Standard Operating Procedures (SOPs) and regulatory requirements.
  • Oversee change control processes effectively.
  • Manage Corrective Action and Preventive Action (CAPA) plans and deviations.
  • Conduct impact assessments for modifications to equipment and processes.
  • Implement risk management strategies.
  • Ensure thorough documentation and investigations meet all compliance standards, making critical decisions that may influence ongoing manufacturing operations.
  • Authorize the release of equipment, systems, or areas.
  • Provide quality oversight for complex change management systems, ensuring adherence to local SOPs and regulatory standards.
  • Perform independent technical reviews of documentation during and after cGMP activities.
  • Verify that all specifications are fulfilled and applicable requirements are satisfactorily completed.
  • Confirm that all issues and documentation related to processes in the assigned area are resolved and compliant before advancing to subsequent steps.
  • Analyze findings and report to relevant departments.

Qualifications:

  • Bachelor's degree in Life Sciences or Engineering.
  • Experience in a team lead or supervisory capacity.
  • Strong attention to detail, organizational skills, and problem-solving abilities.
  • Ability to prioritize tasks and work effectively under pressure.
  • Proficient in MS Office applications (Word and Excel) and related software.
  • Familiarity with SAP systems.
  • Technical knowledge of manufacturing systems, methods, and procedures.
  • Excellent written and verbal communication skills.
  • Understanding of manufacturing processes.

Preferred Skills:

Experience in Quality Assurance, CAPA management, risk assessment, and regulatory compliance within a manufacturing environment is highly desirable.



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