Job Description
Job Description
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :
Description :
Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
Purpose :
The QA Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on : policy & procedure, program management, patient record review, internal / external audit, and metrics and trend analysis and reporting.
Responsibilities :
Responsible for implementing and maintaining the effectiveness of the quality systemProvides effective quality controls to the referral management, call center and fulfillment operationsMonitors compliance with all Plant and Pharmacy Solutions policies and procedures in addition to all federal / state / local governmental and pharmacy laws and regulationsDevelops QA training programs and materials and provides training to departmental personnelEvaluates, analyzes, and trends quality indicators, data, performance metrics and prepares daily / monthly reports of pharmacy solutions quality measurementsManage QA lists, spreadsheets, and databases as required to support the businessParticipates in Quality Improvement initiatives and assures customer satisfactionConducts investigations and provides timely resolutions to variance, incident, exception issues.Participates in the development and implementation of permanent corrective actions.Prepares ad hoc quality and other reports as requested by management and external customersConduct internal audits on the business functions of Pharmacy Solutions and Supports external audit logistics and operations .Qualifications :
BS in a scientific discipline or related experienceMinimum of 2 years’ experience in a Quality related fieldStrong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)Good oral, written, and presentation skillsSound decision making and problems solving skills to assure business unit complianceStrong analytical skills, ability to analyze data and trends and draw conclusionsGood mathematics background with an understanding of basic statistical concepts.Daily Work Schedule Expectations Monday to Friday 8-5PM.
Must be available to work additional time if needed.