Responsible for coordinating various activities related to product manufacture and release in compliance with Company’s Quality System.
Essential Duties and Responsibilities:
Ensures the accuracy and completeness of the QA document system, performs daily filing and organizes contents.
Reviews batch records, QC records, labels and other documentation.
Coordinates the review and revision of procedures, specifications and forms as well as maintaining and updating the document control and tracking databases.
Perform internal audits to ensure compliance.
Identifies quality improvement opportunities, compliance concerns, identify, prevent and resolve deviations.
Coordinates Periodic Procedure Reviews to ensure documents are reviewed on an annual basis.
Maintains and tracks Design and Development Deliverables and Files.
Reviews design requirements documents, design transfer files, R&D Reagent and System Testing, Verification and Validation (Plan, Protocols, etc.).
Additional tasks as may be assigned by department Manager or Director.
Attention to detail and good organizational skills.
High level of reading comprehension.
Must be able to write clear, understandable documentation with effective presentation of information.
Basic computer literacy required.
Experience, Education and Certifications:
Previous training and experience.