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Amneal Pharmaceuticals Supervisor, Quality Assurance in Brookhaven, New York

Description: * The Supervisor, Quality Assurance, schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling and packaging operations, sampling and inspection activities on all work shifts. Essential Functions: * Responsible for scheduling and coordinating daily priorities for incoming raw material, in-process material, finished product and in-process packaging/labeling operations sampling and inspection activities. * Trains, supervises and evaluates the performance of QA inspectors, QA Specialist and QA Auditors to assure compliance with Standard Operating Procedures (SOPs)/cGMP. * Responsible for final product: Monitors all stages of QA in-process/packaging operations to ensure strict compliance with cGMP/SOPs. * Assists management with the development of new and revised SOPs, executes validation & qualification studies, performs investigations and other assignments as required. * Handles Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPA) through effective quality management tools. * Handles customer complaints to include retrieval of samples, performing applicable tests, preparation of reports and submission before due date. * Monitors and ensures that batch records are audited per manufacturing/packaging/shipping requirements,when required. * Conducts internal audits for compliance with SOP, cGMP & FDA requirements. Additional Responsibilities: * Initiates, investigates and completes CAPA for all QA unplanned deviations under the guidance of QA Manager. * Writes, reviews and revises SOPs as directed by QA Manager/Director. * Plans, monitors and supervises cross training of all QA Inspectors. * Monitors absences and prepares Kronos, HR requistions/data change forms for all shift personnel, whenever required. * Reviews performance of all QA Inspectors in the shift as and when directed by HR. Education: * Bachelors Degree (BA/BS) Preferred degree in Chemistry, Biology or other related technical field - Required Experience: * 3 years or more in Supervisory experience in FDA regulated industry, QA Manufacturing * 3 years or more in Prior relevant work experience as a QA Inspector or QA Auditor Skills: * To be a team leader and player who can successfully meet the organization's goals within a stipulated time frame. - Intermediate * Must be able to multitask and adapt to a rapidly changing environment. - Intermediate * Strong communication and writing skills. - Intermediate * Must be able to problem solve and make decisions with limited supervision. - Intermediate * Must be able to lead, coach and supervise the team with flexibility. - Intermediate * Microsoft Office; able to learn in-house computer systems and software. - Intermediate Specialized Knowledge: * Knowledge of cGMPs. Job: Quality Assurance* *Organization: Quality *Title: *Supervisor, Quality Assurance Location: NY-Brookhaven Requisition ID: 200JG