Ensure the laboratory conforms to company policies, SOPs, cGMP and GLP regulations, and FDA regulations. Thus, ensuring that all laboratory personnel use the proper specifications or an associated compendial monograph.
Provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
The Quality Analyst is responsible for medical records reviews and data abstractions; performs analysis and reports, collaborates with other departments and provide appropriate feedback to create effective and sustained change.
Provide periodic analysis of risk management feeders and impact into the risk management process. Including but not limited to capturing new device complaint failure modes in both complaint system and risk management documentation.
The candidate will work with the systems analyst to formalize a testing process that will be effective. The candidate will essentially become an expert on the software and will know both the technical and business side to successfully determine expected functionality.
Coordinates the implementation and maintenance of the Research Regulatory and Quality Assurance (QA) Program for the Institute in collaboration with Institute and central research administration management.
In this role, the selected candidate will define the To-be state of business process and workflow as expected by customer (user and IT teams) along with thought leadership inputs, refinements and improvements which will help the customer to achieve objectives faster and in efficient manner.