Quality Assurance Specialist

5 days ago


Rockville, Maryland, United States Medix™ Full time
Job Title: Quality Assurance Associate

At Medix™, we are seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities:
  • Document Management: Manage the initiation, revision, and distribution of documents in accordance with Good Documentation Practices (GDP) requirements.
  • Quality Investigations: Assist in reviewing production records, testing records, and validation protocols to ensure product integrity and regulatory compliance.
  • Materials Control: Oversee the control of critical and starting materials to ensure their quality and authenticity.
  • Batch Record Management: Help compile and verify batch-related documents for product lot disposition.
  • Deviation and CAPA Management: Support investigations of deviations, non-conforming materials, and CAPAs to ensure prompt resolution and corrective action.
  • Quality Assurance Support: Provide Quality Assurance support for product and manufacturing issues to ensure compliance with regulatory requirements.
  • Tracking and Closing: Assist with tracking and closing non-conformance and CAPA activities to ensure timely resolution.
  • Validation and Audits: Participate in validation tasks and internal audits of the Quality Management System to ensure its effectiveness and efficiency.
  • Equipment and Facility Reports: Review equipment, facility reports, and proposed system changes to ensure compliance with regulatory requirements.
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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