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