Quality Assurance Specialst

This position is primarily responsible for assuring that released raw materials and finished goods have met the required specification criteria prior to release, and to maintain accurate, complete and traceable documentation related to analysis and disposition. This position will also supply support to the production floor in all quality related items and questions. In addition, this position will support continuous development of an FDA / OTC and ISO-compliant quality system that conforms to the Nice-Pak Quality Manual. The Quality Assurance Specialist interacts with Compounding, Production, Customer Service, Purchasing Dept., Training Coordinators, and Warehouse to help facilitate the development, implementation, enhancement, and training for all Quality Systems and Process Improvement programs.

Essential Functions And Basic Duties

• Ensure that documented evidence is provided demonstrating that product meets release criteria.
• Ensure that safety and hazard practices are understood and followed.
• Provide support of quality in the following areas: a. Identification and traceability of components and finished goods. b. Equipment and Process Change Control c. Support Quality Planning and Continuous Improvement
• Ensure compatibility between process capability and Finished Product specifications
• Ensure that all documentation and material is prepared for new production items
• Assure Nice-Pak documentation and records are maintained and archived in accordance with GLP’s, FDA, and established Nice-Pak standards by auditing.
• Support measurement and reporting of Non- Quality Costs.
• Ensure that reporting personnel are trained and qualified to do his/her job by selection, training and evaluation of performance.
• Assist in the follow through, disposition and reporting of nonconformances.
• Organize and report on key quality KPI’s weekly, monthly and as needed.
• Organize and facilitate the rework process to ensure all nonconformance goods are worked in a timely fashion.
• Run reports for tracking and trending of Expired Product, MDR’s, Rejects, Rework, etc.
• Complete Material Destruction Requests as required.
• Run reports for tracking and trending of Expired Product, MDR’s, Rejects, Rework, etc.
• Support FMEA’s for new product launches.
• Assist as required in training plant personnel.
• Manage and support the digital quality system.
• All other duties as assigned. The above is intended to describe the general content of and requirements for the performance job this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.