TOLMAR Inc. QA Compliance Specialist II in Fort Collins, Colorado
Purpose and ScopeThe QA Compliance Specialist II supports Quality Assurance by collecting datafrom the owner departments, compiling and analyzing the data and identifyingtrends in product/process data that can affect product quality. This isaccomplished by compiling relevant data and authoring Annual Product Reviews(APRs).Essential Duties and Responsibilities Complete Annual Product Reviews (APRs) in a timely manner incompliance with regulatory requirements and in adherence to the schedulespecified in the applicable work instruction. Assist system owners in other Tolmar departments with preparing,trending, and analyzing reported data for APRs. Compile information and data for Tolmar s commercial products forauthoring the annual product review report. Working with the system owner and Quality Engineering on ensuring soundstatistical analysis of data, identify trends in the product/process datathat can affect product quality. Summarize results of data compilation and statistical analysis in theAPR technical reports. Ensure all areas of responsibility are completed in adherence to allestablished procedures and requirements. Prioritize work assignments and complete essential duties withinestablished timeframes and deadlines. Perform various other duties as assigned.Knowledge, Skills and Abilities Proficient knowledge in MS Office. Knowledge of QA principles, concepts, systems, industrypractices, and standards. Ability to read, understand, and author complex technical documents. Ability to apply logical thinking in order to link quality systems andable to identify if there are gaps. Excellent communication skills demonstrated through interactionsinternally and externally. Ability to work independently and in conjunction with a team on multipleprojects simultaneously in order to meet timelines. Effective organization and project management skills. Strong attention to detail, thorough, and efficient. Understanding of statistical software packages, control charting,statistical trending rules, and/or project management experience preferred.Core Values The QA Compliance Specialist II is expected to operate within theframework of Tolmar 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 Bachelor s degree in Chemistry, Engineering, Biology or otherrelated field required. Five or more years experience in the pharmaceutical, medicaldevice, or biotech industry required. CSSGB, CSSBB, or CQE preferred.Working Conditions Working conditions are normal for an office environment. Work mayrequire occasional weekend and/or evening work. Remote work arrangements may be considered.