Quality Assurance Specialist

3 weeks ago


Boca Raton, United States Medix™ Full time

Responsibilities

  • Perform direct oversight of production/compounding activities to ensure cGMP compliance.
  • Perform equipment start-up and line clearance verifications.
  • Perform real-time Batch Record Reviews on the floor during operations.
  • Submit laboratory samples following procedures.
  • Verify production/compounding area cleanliness, environmental status, and room documentation before authorizing use of the facility/area.
  • Monitor work in process for proper use of materials, correct recordings, and possible sources of cross-contamination and report all deviations to the QA Supervisor.
  • Inspect and approve the use of designated equipment after a product changeover.
  • Adhere to all cGMPs, compliance/regulatory mandates, and quality requirements.
  • Perform other related duties as assigned to meet departmental and Company objectives.
  • Maintains a safe and healthy work environment by following standards and procedures; and complying with legal regulations.
  • Maintaining records of inspection and testing through an electronic system.
  • Initiate non-conformances and deviations, ensuring that only acceptable products are sent to customers
  • Being an active part of the team, helping to eliminate production obstacles to increase productivity.
  • Interact with management and floor supervision on errors and process improvements.

Requirements

  • Quality experience required with a strong understanding of quality control standards and testing techniques.
  • Efficient in using a computer and Microsoft Office.
  • Possess strong verbal and written communication skills.
  • Prefer prior experience in FDA-regulated industries and knowledge of ISO and GMP regulations.
  • Bilingual (English and Spanish, spoken and written) a plus.
  • Simple addition and subtraction calculations.
  • Must be able to follow written instructions and specifications under cGMP (Good Manufacturing Practices) guidelines, as well as company policy, safety guidelines, and manufacturing rules.
  • Good documentation practice is a must.
  • Work independently with a strong aptitude for detail.

Education

BS in Biology, Chemistry or related field

2-4 years of experience in a GMP setting performing quality assurance related tasks

Expereince with the following:

  • Provide Quality Assurance support for the technical release of clinical batches.
  • Responsible for the management, control and release of critical materials and starting materials.
  • Perform quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, change requests, and CAPA


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