Quality Assurance Specialist

5 hours ago


Rockville, Maryland, United States Medix™ Full time
Job Summary

We are seeking a highly skilled Quality Assurance Associate to support our document management, materials control, and compliance with Good Documentation Practices (GDP) and GMP standards.

Key Responsibilities
  • Document Management: Manage initiation, revision, and distribution of documents per GDP requirements.
  • Quality Investigations: Assist in reviewing production records, testing records, and validation protocols.
  • Materials Control: Oversee the control of critical and starting materials.
  • Batch Documentation: Help compile and verify batch-related documents for product lot disposition.
  • Quality Support: Support investigations of deviations, non-conforming materials, and CAPAs.
  • Manufacturing Support: Provide Quality Assurance support for product and manufacturing issues.
  • Non-Conformance Tracking: Assist with tracking and closing non-conformance and CAPA activities.
  • Validation and Audits: Participate in validation tasks and internal audits of the Quality Management System.
  • Equipment and Facility Reports: Review equipment, facility reports, and proposed system changes.
Qualifications
  • Education: Bachelor's Degree in life sciences or a related field.
  • Knowledge and Skills: Knowledge of cGMP principles and FDA regulations, familiarity with aseptic processing and quality systems, strong communication, problem-solving, and teamwork skills.


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