<p>Job Description:</p> <p>SUMMARY:</p> <p>Provides moderately complex analyses in a microbiological environment within defined procedures and practices. Performs microbiological methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or method development testing. Supports internal development and/or manufacturing operations. Makes detailed observations, reviews documents, and communicates test results; recommends solutions.</p> <p>ESSENTIAL FUNCTIONS:</p> <ul> <li>Conducts moderately complex microbiological testing of pharmaceutical raw materials, packaging components, finished products, environmental monitoring, and stability samples by internally developed and compendial test methods. </li><li>Recognizes and reports out-of-specification or unexpected results and non-routine product problems; recommends solutions. </li><li>Maintains and troubleshoots analytical instrumentation as needed. </li><li>Clearly and accurately communicates the results of work by detailing the testing/analysis and acquired results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients. </li><li>Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients. </li><li>Writes SOPs and other instructional documents. </li><li>Cleans and coordinates work area, instrumentation, and testing materials. </li><li>Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards. </li></ul> <p>EDUCATION:</p> <ul> <li>Bachelor's degree in physical science, preferably in Microbiology, Biology, or Natural Science. </li></ul> <p>EXPERIENCE:</p> <ul> <li>Typically requires a minimum of 2 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. Experience with aseptic technique and common office software. </li></ul> <p>EQUIVALENCY:</p> <ul> <li>Equivalent combinations of education, training, and relevant work experience may be considered. </li></ul> <p>PROFICIENCIES:</p> <ul> <li>Experience with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Proficient in the understanding and application of aseptic technique, environmental monitoring, and identification of microorganisms. </li><li>Effective written and interpersonal skills with the ability to interact with Auditors if there is a need. </li><li>Strong proficiency in Microsoft Office Suite (Word, Excel, and Power Point). </li><li>Ability to multitask by working on multiple projects simultaneously, and able to adapt and change priorities when business needs demand a shift in priority. Ability to work weekends when needed based on business needs. </li></ul> <p>REQUIRED:</p> <ul> <li>Good knowledge and understanding of analytical instrumental technologies. </li><li>Good knowledge of qualitative and quantitative microbiological analysis. </li><li>Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs. </li><li>Good problem-solving skills and logical approach to solving scientific problems. </li><li>Proficiency with Environmental Monitoring, Microbial Limits Testing, Growth Promotion, Media Quality Control, and Method Development (preferred). </li><li>Ability to read, analyze, and interpret technical procedures and governmental regulations. </li><li>Ability to write standard operating procedures, simple protocols, and reports. </li><li>Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques. </li></ul> <p>PHYSICAL REQUIREMENTS:</p> <p>Position requires physical coordination for office tasks, including sitting, standing, walking, lifting 10-35 pounds, typing, and using equipment.</p>