Serve as a process owner for the change control system.Serve as quality , regulatory and validation support for the site . Serve as quality assurance liaison for customer project teams. Create , review and approve risk assessment and impact analysis as needed for new products, processes and equipment. Review and approve all test methods and associate protocols.Responsible for risk management as it relates to quality assurance activities. Review and approve new material for manufacturing use. Initiate quality hold and deviation and approves deviation investigation.

Par Pharmaceutical, Rochester, MI From Sept 2015 to present Specialist II, MQA Reviews and approves deviations, investigation and associated with CAPA. Evaluate Effectiveness of completed CAPAs through continuous analysis of deviation Trends. Enforcement of quality standards and process controls. Plays an active role in solving compliance errors when detected during GMP processes. Assist in training of new colleagues. Recognizes problems within scope of job and promptly and clearly communicates them to management. Manually inspects samples for visual quality defects and variations in such properties as size, shape, color, clarity. Manually inspects finished product packages for defects in assembly line. Classifies and records defects and observations on approved applicable forms in accordance with Good Documentation Practices. Performs on line and offline review of batch records. Able to use and interpret the AQL Slide Rule for determination of AQL sampling plans. Responsible for alerting QA management of any deviation encountered during the sampling and inspection process.

 Responsible for bulk inspection √N + 1 related to coated tables, capsules, chewable are finished product and goes to packaging line for final shipping to customer Collect sample of raw materials to be checked by the QC Lab to meet the SOP standard Provide accurate and complete data entry records of samples from bulk tablets, capsules, and soft gels Obtain and evaluate composite sample for defects and report total percent of defects found in the bulk Retention of contaminated sample if required with valid data as per name, lot number/code and sample data and retain all facts until investigation completed and final disposition determined Sensory Evaluation of powders and chewable or flavored tablets performed after the finished product comes to the lab Maintain all safety precautions for employees Gained expertise in testing and maintaining consistency in quality production Review and approve or reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to the documents Review and approve or reject reprocessing and rework procedures Review and approve or reject production batch records and make the final decision to release a product lot into commerce