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TOLMAR Inc. QA Associate II - Process in Fort Collins, Colorado

DescriptionPurpose and ScopeThe Quality Assurance Associate ensures that all product manufactured atTolmar is manufactured in accordance with current Good Manufacturing Practices(GMP) and meet all internal specifications. They will also provideoversight and guidance to manufacturing personnel in the performance of theirduties.Essential Duties and ResponsibilitiesInspect materials, components, and finished product against specifiedrequirements.Follow procedures to determine status or disposition, and properly documentresults on records and in lab notebooks.Perform inspection of retained drug product for Annual Product Reviews.Support manufacturing and QC unit with inspections and material sampling.Training of associates on various job functions.Complete training according to requirements and maintain training records inthe electronic document system.Ensure proper status and storage of materials and product.Provide materials to outside departments as requested.Update SOPs and work instructions using the electronic document managementsystem.Complete review and release of materials as required.Provide quality oversight throughout multiple departments and facilities.Initiate deviations, complete immediate actions and request assessments fornon-conformances from appropriate groups (i.e. Packaging Engineering).Participate in monthly quality and safety walkthroughs.Perform finished product inspections in accordance with specification;ensuring proper sampling has taken place prior to final release.Provide process oversight support to manufacturing.Understand and use the electronic document/documentation system in theperformance of duties.Suggest improvements to streamline inspection and documentation processes andwork with manufacturing department to assure success.Demonstrate high level of proficiency in department job functions.Reach sound, effective conclusions and make quality decisions with little orno supervision.Assist Quality Assurance management with investigations.Complete corrective and preventative actions as determined throughinvestigations.Contribute to Competency Based Training (CBT) as a subject matterexpert, acting in a Developer, Trainer or Assessor capacity.Perform various other duties as assigned.Knowledge, Skills and AbilitiesWorking knowledge in drug or device cGMP.Knowledge of computer operations, including proficiency with MS Word,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 ValuesThe QA Associate II is expected to operate within the framework of Tolmar'sCore Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task. Education and ExperienceHigh school diploma or GED required.Associate's degree preferred.Experience in a high volume manufacturing environment preferred.Two or more years' experience in the pharmaceutical or medical deviceindustry in a Quality Assurance capacity.Additional RequirementsAbility to bend, squat, and lift minimum of 30 pounds required.Ability to pass physical and eye exam required.Ability see color required.Working ConditionsCore hours for this position are Wednesday - Saturday from 5:00 am - 5:30pm, with alternating Wednesdays off.Working cond