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QC Analytical Specialist

2 months ago

Gaithersburg, Maryland, United States Kaztronix Full time
Job Summary

Kaztronix is seeking a highly skilled QC Analytical Specialist to join our team. As a key member of our Quality Control department, you will be responsible for providing technical expertise to support the development and implementation of analytical methods and procedures.

Key Responsibilities
  • Method Lifecycle Management: Contribute to the development and implementation of analytical methods and procedures to ensure compliance with regulatory requirements.
  • Method Transfers and Validations: Lead the transfer and validation of analytical methods to internal and external laboratories, ensuring seamless integration and compliance.
  • Technical Expertise: Provide analytical technical expertise to support manufacturing deviations and OOS/OOT investigations, working closely with Manufacturing and Quality Assurance teams.
  • Collaboration and Communication: Serve as a technical liaison between Quality Control and Analytical Development, representing QC on cross-functional teams focused on solving complex product and analytical issues.
  • Documentation and Reporting: Author deviations, investigations, and technical reports, ensuring accurate and timely documentation.
Requirements
  • Education: B.S. in Biochemistry, Chemistry, or related scientific discipline.
  • Experience: At least 6 years of experience in the biopharmaceutical industry, with a strong background in analytical methodologies and method transfers and validations.
  • Skills: Demonstrated scientific knowledge and experience in analytical methodologies, broad knowledge and experience in method transfers and validations, established knowledge of applicable global drug development and regulatory standards, and excellent communication skills.