Documentation Specialist

2 days ago


Santa Monica, California, United States Collabera Full time
Job Description

Collabera is seeking a highly skilled Documentation Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the accuracy and completeness of batch-related documentation.

Key Responsibilities:
  • Batch Documentation Review: Conduct thorough quality reviews of batch-related documentation to ensure all issues are resolved prior to product release.
  • Batch Disposition: Oversee batch disposition by ensuring that all processes comply with established process controls and regulatory requirements.
  • Deviation Management: Initiate, investigate, and resolve product-related deviations in accordance with quality guidelines and regulatory standards.
  • CAPA Management: Ensure that all necessary Corrective and Preventive Actions (CAPAs) are initiated, investigated, and resolved efficiently.
  • Documentation Management: Generate, update, and maintain quality-related documents, including procedures and forms, to ensure compliance with the latest standards.
  • Cross-functional Representation: Act as the QA representative at plant and multi-site scheduling meetings, as well as at disposition meetings, ensuring quality oversight across multiple locations.
  • Project Participation: Represent the QA department on various projects and in cross-functional team meetings, providing quality input and ensuring adherence to quality objectives.
  • Metrics Reporting: Maintain and report key metrics related to product disposition to support Management Reviews and continuous improvement initiatives.
  • Audit and Inspection Support: Participate in and support internal and external inspections and audits to ensure regulatory compliance and adherence to quality standards.
Qualifications:
  • Bachelor's Degree: In a scientific or technical field preferred.
  • Experience: Minimum of 3-5 years of experience in quality assurance or quality operations, preferably within a regulated manufacturing environment.
  • Knowledge: Strong knowledge of quality management systems, regulatory compliance, and manufacturing processes.
  • Skills: Experience with batch record review, deviation investigation, CAPA management, and document control.
  • Attributes: Exceptional attention to detail and strong problem-solving skills.
  • Communication: Excellent communication and interpersonal skills, with the ability to represent QA in cross-functional settings.
  • Management: Ability to manage multiple priorities and work in a fast-paced environment.
  • Metrics: Experience with metrics tracking and reporting in support of continuous improvement.
Job Requirements:
  • Quality Assurance
  • Quality Control
  • Batch Documentation
  • Batch Record
  • Batch Records
  • CAPA
  • Corrective Actions
  • Documentation Management
  • Audits
  • Inspection
  • GMP
  • GLP
  • Medical Device
  • FDA
  • ISO


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