TOLMAR Inc. QA Associate I - Process in Windsor, Colorado
Purpose and ScopeThe Quality Assurance Associate I is responsible for the inspection,testing, record keeping and overall quality assurance support to manufacturing.Essential Duties and Responsibilities Inspect material, components, and finished product against specifiedrequirements. Follow procedures to determine status or disposition, and properlydocument results on records and in lab notebooks. Support manufacturing and QC unit with inspections and material sampling. Complete training according to requirements and maintain trainingrecords in the electronic document system. Perform finished product inspections in accordance with specification;ensuring proper sampling has taken place prior to final release. Provide process oversight support to manufacturing. Ensure proper status and storage of materials and product. Complete review and release of materials as required. Provide quality oversight throughout multiple departments and facilities. Initiate deviations and complete immediate actions. Participate in monthly quality and safety walkthroughs. Perform various other duties as assigned.Knowledge, Skills and Abilities Working knowledge in drug or device cGMP. Knowledge of computer operations, including proficiency with MSWord, Excel and Access. Ability to learn Tolmar s electronic systems. Skill in organization and attention to detail. Skill in effective written and oral communication. Work independently and properly prioritize tasks with limited supervision. Ability to work well with employees at all levels and departments. Ability to read, understand and follow procedures. Demonstrate competency in technical writing. Ability to use critical thinking to address potential areas of concern.Core Values The QA Associate I 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, GED, or equivalent required. Associate s degree preferred. Experience in a high volume manufacturing environment preferred. Experience in a Quality Assurance capacity in the pharmaceutical ormedical device industry preferred.Additional Requirements Ability to bend, squat, and lift minimum of 30 pounds required. Ability to pass physical and eye exam required. Ability see color.Working Conditions Working conditions are in an office, warehouse and manufacturingenvironment. Occasional overtime may be required. Work may consist of travel between multiple facilities.