In this role, you will perform evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
Provide support to customer audits including: direct support to customer audit host, coordinate audit requests, meals, and serve as an alternate audit host, assist in the process of scheduling customer audits.
The Quality Improvement Specialist-Nursing under the supervision of the Quality Manager performs services in Regulatory Compliance according to the policies, procedures, philosophy, and objectives of the department and hospital.
The Sr. QA Specialist GCP/PV will play a pivotal part in the companys plans for expansion by bridging the gap between the Quality and Pharmacovigilance teams to achieve efficiency and to ensure GCP compliance.
Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may include weekend assignments.
Lead cross-functional process teams in a matrixed environment to develop and implement Quality processes by inventorying existing systems, assessing gaps and opportunities for improvement, collecting stakeholder and customer feedback and implementing robust business process management (BPM) including documentation and change control.