TOLMAR Inc. Quality Operations Process Supervisor in Windsor, Colorado
Purpose and ScopeProvides direct supervision of a team of QA associates. Responsible foroverseeing the daily operations of the Process Quality team. Providesguidance to ensure compliance with procedures and regulations for QAmanufacturing support.Essential Duties and Responsibilities Manage the development, implementation and maintenance of QualityAssurance systems and activities. Review and approve documents used in Good Manufacturing Practicesthrough the document management system. Provide quality oversight related to manufacturing processes. Perform investigations associated with the Quality Operations department. Review and approve minor deviations. Develop materials for and administer Competency Based Training (CBT). Review and approve certificates of analysis for raw materials. Identify training needs for direct reports and ensure compliance withtraining requirements. Prepare and administer employee appraisal and performance documentation. Assist Manufacturing and QA departments as needed in process improvementprojects. Provide KPI data for Right the First Time for quality operationsdepartment. Supervise the following activities of QA employees to ensure schedulesand performance requirements are met:o Time off request managemento Material and labeling sampling and inspectiono Finished product sampling and inspectiono Retains of productso Manufacturing supporto Cleaning and monitoring of inspection areas Perform various other duties as assigned.Knowledge, Skills and Abilities Knowledge in cGMP and ISO 13485. Excellent working knowledge of current Good Manufacturing Practices forFinished Pharmaceuticals and/or Medical Devices. Skill in effective oral and written communication. Skill in Procedure writing. Skill in effective computer operation. Ability to coordinate activities to assure customer needs are met. Ability to work effectively within multi-disciplinary project teams. Ability to gain understanding and acceptance from others in sensitivesituations. Ability to be independent, organized, and to lead others to meet deadlines.Core Values The QA Supervisor is expected to operate within the framework ofTolmar s Core Values:o Consistently operate with the highest standards of ethics and compliance.o Take ownership of your actions, success and setbacks.o Respect each other and understand that honest collaboration is at theheart of our company success.o Go the extra mile to make things happen.o Be committed to all we do and the patients we serve.o Embrace change with enthusiasm.o Strive to learn about and understand the needs of customers andpatients, and take action with great speed and efficiency no matter the task.Education and Experience High school diploma or GED required Bachelor s degree in scientific discipline or related fieldpreferred, not required. Six or more years of experience in the pharmaceutical or medical deviceindustry in Quality Assurance (or equivalent combination of education andexperience).Working Conditions Working conditions are normal for an office environment. Weekends andovertime may be required.