Senior Quality Assurance Specialist

4 weeks ago


Hartford, Connecticut, United States KVK Tech Full time
Job Summary

We are seeking a highly skilled and experienced Technical Reviewer to join our Quality Assurance team at KVK Tech. The successful candidate will be responsible for ensuring the accuracy and completeness of laboratory raw data, procedures, and reports, and will play a critical role in maintaining our company's high standards of quality and compliance.

Key Responsibilities
  • Review and comment on laboratory raw data, procedures, and reports to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
  • Interface with analytical groups, QA, and other stakeholders to ensure seamless communication and collaboration.
  • Provide feedback to analysts and supervisors on review findings and ensure necessary actions are taken to correct or prevent errors.
  • Develop and maintain a systematic approach to review data and ensure compliance with procedures and specifications.
  • Perform audits and reviews as required, and provide recommendations for process improvements.
Requirements
  • Bachelor's degree in Chemistry or a related field.
  • Minimum 1-year experience with instrumental techniques, with 2+ years of experience in a GMP lab using HPLC, GC, and/or related analytical techniques.
  • Strong analytical and problem-solving skills, with attention to detail and ability to work independently.
  • Excellent communication and interpersonal skills, with ability to interface with cross-functional teams.
  • Knowledge of cGMP guidelines and DEA regulations.


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