QA Specialist

Company: PLZ Aeroscience Corporation
Location: Fall River
Posted on: January 17, 2022

Job Description:

Primary Purposes: Create, revise and control the OTC Master Batch packets for use when running OTC products. Responsible for coordinating and or collecting and preparing sample shipment based on customer request. Inspect and prepare Product Sample Retains for raw materials, bulk and finished goods samples collected, which need to be sent out for testing or retained. Assist in sampling of DI Water and testing requirements. Cross trained on various job functions. Reports To: Manager, Quality Essential Duties and Responsibilities: Responsible for inspecting and or collecting finished goods samples for Customer approvals as per Customer requirements and prepare samples to be given to the shipping department. Cross trained for collecting raw materials, bulk and finished goods samples for testing (ex. Micro, Assay). Send samples out in a timely manner. Maintain customer sample requirements and the documentation. Follow up on test results. Cross train customer retain program (ex. OTC retain requirement verses Cosmetic retain requirements). Cross train on performing DI water sampling and testing on a routine basis (Monthly). Assist QA/RA Manager on nonconformance investigations and following up on the product dispositions. Prepare and provide C of A's and C of C's to customers. Prepare and maintain documentation for over-the-counter (OTC) products. Create, revise and control OTC Master Batch packets for use when running OTC products. Review all OTC documentation and data generated during OTC product runs. Produce COAs and release documents to release all OTC production for shipment and other COAs requested by customers for their products. Assist with the Annual Drug Product Reviews for all OTC products. Maintain Retain Storage area for OTC drug products and other products requiring retention period greater than 2 years. Cross Trained on QC and QA job functions and perform other related duties as assigned. Skills & Qualifications: 3+ year experience in the Quality field preferred Experience in performing inspections Experience with Material Review Board process Experience with document control Computer skills (Word, Excel and Outlook) Education/Training/Experience: High School Diploma or GED preferred

Keywords: PLZ Aeroscience Corporation, Fall River , QA Specialist, Other , Fall River, Massachusetts