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 developing innovative treatment solutions for unmet medical needs. We are currently seeking a skilled Batch Record Reviewer II to enhance our Quality Assurance team. This position offers a unique opportunity to contribute to pioneering therapies and positively impact patient outcomes.

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 role 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:

  • Ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements.
  • Manage change control processes effectively.
  • Oversee Corrective Action and Preventive Action (CAPA) and Deviation management.
  • Conduct impact assessments for modifications to equipment and processes.
  • Implement risk management strategies.
  • Verify that documentation and investigations fulfill all necessary criteria, making prompt decisions that may directly influence ongoing manufacturing operations.
  • Authorize the release of equipment, systems, or areas.
  • Provide quality oversight for the change management system, particularly for complex Minor and Major classified Change Controls, ensuring adherence to local SOPs and regulatory compliance.
  • Perform independent technical reviews of documentation during and after cGMP activities.
  • Confirm that all specifications are met and applicable requirements are satisfactorily completed.
  • Ensure resolution and approval of all issues/documentation associated with processes in the assigned area before advancing to subsequent steps, maintaining compliance with cGMPs, SOPs, and relevant manufacturing regulations.
  • Analyze and communicate findings to relevant departments.

Qualifications:

  • Bachelor's degree in Life Sciences or Engineering.
  • Experience in a leadership or supervisory role.
  • Strong attention to detail, organizational skills, and interpersonal abilities.
  • Proficient in prioritizing tasks and working effectively under pressure.
  • Able to respond quickly in a dynamic work environment.
  • Demonstrated proficiency in Microsoft Office Suite (Word and Excel) and related software.
  • Familiarity with SAP.
  • Technical understanding of manufacturing systems, methods, and procedures.
  • Excellent written and verbal communication skills.
  • Awareness of manufacturing processes.

Preferred Skills:

Experience in Quality Assurance, CAPA, Risk Management, Change Control, and a solid understanding of cGMPs and regulatory compliance.

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