QA Specialist II - 2nd Shift

Quality Assurance CoordinatorThis position is primarily responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by performing the following duties.Four-year college degree or master's degree; and two to three years related experience and/or training; or equivalent combination of education and experience.Ensures compliance with cGMP, Company SOPs and FDA requirements during all phases of operations.Sampling and disposition of Packaging Materials and Packaging Components as per standard operating proceduresSupport raw material sampling as needed.Issuance of Batch Manufacturing records and Batch Packaging Records as per requirements.Disposition of raw materials and finished products as per standard operating procedures.Prepares and maintains vendor qualification reports and its requalification reports.Prepares, maintains and issues raw material specifications.Prepares and maintains analytical specification for raw material testing and retest.Organizes and ensures accurate and reliable filing systems for all paper-based GMP Documents.Review of executed batch manufacturing and packaging records.Prepare shipment for samples as per requirements for customers.Completes quality assurance operational requirements by scheduling or co-ordinationPrepares and maintains all Quality Systems, including CAPA, Complaint Handling, Deviations, Nonconforming Product, and Internal Auditing to comply with regulatory requirements.Prepare and maintain master manufacturing record, COA, SDS, finished product /packaged product specification.Preparation of Annual Product Quality Review.To ensure appropriate storage, issuance, periodic visual inspection and destruction of retain samples.To provide all required information in time as requested by the customer.To ensure appropriate storage, issuance and destruction of retain samples.Other duties as assigned by management.