Quality Assurance Specialist

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

#MedixLS