Principal Duties and Responsibilities May perform routine test article/product preparation according to work instructions. May execute routine testing per SOPs, with appropriate data analysis. Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to Management. May provide on the job training. Assure testing/test article preparation is performed within due dates. May prepare and maintain cell lines and reagents required for testing, as applicable for primary department. Maintain relevant supplies, materials, and equipment used in routine testing. Maintain ancillary records (logbooks, worksheets). Conduct routine studies independently. May be requested to conduct more involved studies. Participate in the improvement of documents, test systems, quality systems, and workflow. May be responsible for checking laboratory equipment, being on-call, and responding to continuous monitoring alarms. The associate will respond in accordance with criteria outlined in Standard Operating Procedures. May perform Environmental Monitoring, clean and disinfect cleanroom suites. May order and/or stock supplies subject to approval. May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data. Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required. May be required to operate autoclave. Qualifications and Skills Bachelor's degree in scientific discipline appropriate for hiring department and at least two years of related laboratory experience, or a high school diploma with at least 6 years of relevant laboratory experience. Technical Competencies Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP. Knowledge of metric system, scientific applications, experimental design, and data evaluation. Can draft technical documents and communications (SOPs, protocols, Trackwise records). Proficient at applicable systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department. Ability to work in GMP/GLP environment.