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Quality Assurance Specialist

2 months ago

College Station, Texas, United States Mastech Digital Full time
Job Summary

Mastech Digital is seeking a highly skilled Quality Control Microbiologist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and safety in our sterile manufacturing operations.

Key Responsibilities
  • System Management and Configuration: Experience with MODA-EM and LIMS system, including system management, understanding test configurations, and user requirements.
  • Trending Programs and Protocols: Develop trending programs, EMPQs, testing protocols, and test methods to ensure compliance with regulatory guidelines.
  • Aseptic Processing and Sterile Manufacturing: In-depth understanding of aseptic processing and sterile manufacturing operations, including biologics manufacturing.
  • Qualification Protocols and Testing: Experience with biological indicators, qualification protocols, and microbial testing.
  • Quality Improvement and Continuous Improvement: Lead continuous improvement projects and quality improvement plans to ensure the highest standards of quality and safety.
  • Regulatory Compliance: Good understanding of regulatory guidance documents, including FDA, EU, and JP.
  • Environmental Monitoring and Utilities Monitoring: Experience with bioburden testing, endotoxin testing, environmental monitoring, and utilities monitoring (compressed air, gases, and water).
  • Data Analysis and Reporting: Analyze environmental monitoring data, establish alert and action limits, and perform risk assessments.
  • Technical Reporting: Write technical reports to document findings and recommendations.
Requirements
  • Experience: Proven experience in quality control, microbiology, and sterile manufacturing.
  • Skills: Strong understanding of MODA-EM and LIMS system, trending programs, and qualification protocols.
  • Education: Bachelor's degree in Microbiology, Biology, or related field.