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Documentation Specialist

2 months ago

Santa Monica, United States Collabera Full time

We are seeking a dedicated Quality Assurance Specialist to join our team at the El Segundo, CA site. The individual in this role will participate in quality activities to ensure compliance with applicable quality objectives and regulatory requirements. The QA Specialist will be responsible for reviewing batch-related documentation, performing comprehensive batch reviews, ensuring process control measures, resolving deviations, and initiating CAPAs. Additionally, the QA Specialist will provide quality representation at meetings and support inspections and audits.


Key Responsibilities:

  • Batch Documentation Review:
  • Conduct detailed reviews of batch-related documentation to identify and resolve issues before product release.
  • Perform comprehensive quality review of batches to ensure disposition readiness.
  • Process Control:
  • Ensure that process control measures are implemented and followed during product manufacturing.
  • Deviations and CAPA Management:
  • Ensure all product-related deviations are properly initiated, investigated, and resolved in a timely manner.
  • Ensure that associated CAPAs are initiated, tracked, and resolved as needed to maintain compliance.
  • Documentation:
  • Generate, update, and manage quality procedures, forms, and other documentation in line with company policies and regulatory standards.
  • Meeting Representation:
  • Represent Quality Assurance Operations and product disposition at plant and multi-site scheduling meetings.
  • Provide QA representation at multi-site disposition and team meetings, ensuring quality objectives are consistently met.
  • Metrics and Reporting:
  • Maintain and track metrics related to product disposition to support Management Reviews and continuous improvement initiatives.
  • Audit and Inspection Support:
  • Actively support and participate in internal and external inspections and audits, ensuring preparedness and compliance.


Qualifications:

Education:

  • Bachelor’s degree in Life Sciences, Engineering, or a related field.


Experience:

  • 2-5 years of experience in a Quality Assurance role within a regulated environment, preferably in pharmaceuticals, biotech, or medical devices.


Skills:

  • Strong knowledge of GMP, CAPA, and deviation management processes.
  • Excellent attention to detail and problem-solving skills.
  • Effective communication and collaboration skills to work with cross-functional teams.
  • Ability to manage multiple tasks and work in a fast-paced environment.