Overview : This position is responsible for quality systems in the Quality Assurance team. Performs responsibilities associated with the different quality systems; assures that establishment, customer and regulatory standards are met within the defined quality systems; provides technical and procedural input for improving the quality systems; participates in necessary training; is a technical resource for the QA Management; other duties as assigned. MAIN DUTIES & RESPONSIBILITIES Ensure Safety & GMP's are followed and all discrepancies are reported to the QA Supervisor Interact regularly with the quality team and other departments to insure product has the necessary documentation as required by the customer and regulatory requirements Accurate communication with Quality Management regarding the status of products and documentation Create and review Quality documentation and records as per established specifications Be a “back-up” for the other Quality Support Handle customer and internal retains in an organized and timely manner Create certificates of analysis (COA's) for all finished goods and additional documents, as needed Performs final quality reviews and release of finished product for shipping Conduct and participate in general and quality systems training. Provide specific technical and procedural input in the creation and implementation of written procedures Accountable for the quality of work Accurate and timely recording of information on specified documents Proper use and care of equipment and materials issued to work area Other duties as assigned Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as outlined above. Ability to operate-use personal computer, office equipment, telephone, and various word processor and spreadsheet software. Ability to exchange information with others clearly and concisely; to present ideas, facts, and technical information. Ability to work with minimal direct supervision. Ability to work well with others in a team environment. Zero (0) to one (1) year of related experience or additional years of education and experience may be substituted for each other, as determined by Human Resources and the QA Manager. Ability to effectively present information and respond to questions from QA Supervisor, other internal departments and Customers. Must be able to understand, speak, read and write in English in order to perform the essential functions of the job as they relate to comprehension of laws, regulations, standards, documents and other internal and external communications. Ability to keep proprietary information confidential is critical to this position. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Knowledge of both standard and metric systems. Work Conditions Subject to normal office environment, but must occasionally enter production areas, which may include the following conditions: High noise levels Dust, fumes and odors Subject to various means of business travel (planes, trains, buses, automobiles) Note: This job description is not intended to be all-inclusive. Salary is dependent upon experience and internal and external salary conditions. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship .