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Quality Control Analyst III
Ref No.: 15-03763
Location: Lynnwood, Washington
Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. Conducts data review and preliminary evaluation of results. Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provides input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.

Experience: 6 to 9 years.

Skills:
Experience in critical utility monitoring, including water, steam, compressed air Perform Environmental Monitoring, including surface, particulate and viable air monitoring.
Experience in Biological Indicator Testing Experience in Endotoxin Testing Experience in Bioburden Testing Experience in Media Qualification Experience in and microbial identification Experience in in-process and BDS release assays Experience in cell bank testing release assays Receipt and disposal of samples in the QC lab Troubleshoot assay and instrument problems with Laboratory Supervisor Participate in writing and revising SOPs, protocols Assist in the development and optimization of testing methods Perform and document investigations in support of Alert, Action and OOS results Participate and perform special studies & projects assigned to microbiology
Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
Author complex and explicit documentation (Protocols and technical reports).
Involvement in equipment qualification (IQ, OQ, and PQs) and method validation.
Perform routine data review
Perform validation and product data review Perform routine data trending and reporting Perform other additional job related duties as required
Provide guidance, training and technical leadership to less experienced staff
Prepare statistical analysis of results and write technical reports

Education:
Bachelor's Degree in Life Sciences discipline and 5-8 years experience in cGMP lab environment Master's Degree in Life Sciences discipline and 3-6 years experience in cGMP lab Environment Proficient in Outlook and MS Word and Excel and lab based data management systems Scientific technical writing ability