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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: 3 years
kills: This individual will report to the QC Supervisor and will contribute to general operations and testing of the QC BFT lab. QC Analyst I works independently under general supervision. Primary responsibilities include, but are not limited to the following: collect and process samples in a timely manner, microbiological routine testing of environmental, critical utility, in-process, validation samples, BDS and drug products in accordance with SOPs and cGMP regulations; review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
Major Responsibilities and testing may include but are not limited to:
Perform critical utility monitoring, including water, steam, compressed air Perform Environmental Monitoring, including surface, particulate and viable air monitoring.
Perform Biological Indicator Testing
Perform Endotoxin Testing
Perform Bioburden Testing
Perform Media Qualification
Make specialized QC medias
Receipt and disposal of samples in the QC lab Autoclave QC micro equipment Troubleshoot assay and instrument problems with Laboratory Supervisor Enter data in LIMS and Apollo database as necessary General maintenance of Lab equipment Participate in writing and revising SOPs Assist in the development and optimization of testing methods Maintain log books Ensure labs are clean and safe (in compliance with CGMP) and properly stocked Make detailed observations in support of Alert, Action and OOS result investigations Participate in the qualification of equipment, methods, and processes 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.
Perform other additional job related duties as required
Education: Bachelor's Degree in Life Sciences discipline
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