Student Veterans of America Jobs

Description

Core Hours: Monday - Friday, 8am-5pm Purpose and Scope The Sr. Microbiology Information and Data Specialist is accountable for the use and maintenance of the Microbiology laboratory's computer systems and analysis of data generated. Essential Duties & Responsibilities Serve as person responsible for ensuring that validation and maintenance of the validated state of cGMP critical associated software and computer systems is completed in accordance with established policies and procedures. Provide data analysis, tracking and trending reports, and updates for the Environmental Monitoring (EM) program and product release through use of MODA, MIMS, Endoscan and LIMS and other related software. Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements Responsible for editing and approving samples in MODA, as well as the generation of MODA reports for trends and release of product. Ensure accuracy when generating data from MODA, MIMS, endoscan and LIMS, and other applications/databases for Microbiology projects, trend analysis, and investigations. Review data and performs trend analysis utilizing MODA, MIMS, Endoscan and LIMS. Assist with training individuals on accurate data entry and use of MODA, and other department software, as needed. Create and revise MODA sample plans as required. Provide user access to MODA and other systems. Perform periodic review of MODA and other microbiology department computer systems. Support the laboratory Director with project proposals related to functional responsibilities. Attend training sessions on GMP, statistics, and software as needed. Provide support to the Microbiology department for the evaluation and implementation of new technological innovations in laboratory automation systems, documentation systems and other technologies. Assist laboratory personnel and quality management with issues related to laboratory instrumentation, computers, software, and related databases. Generate ad-hoc reports of historical results of testing performed in the Microbiology lab for laboratory management as well as other departments. Write and maintain standard operating procedures as needed. Upon assignment by management, resolve testing issues including Out of Specifications and investigations for commercial, stability and developmental samples. Upon assignment by management, resolve MODA-related issues or queries of data to support testing issues or regulatory inspections. Support MODA IT tickets to ensure timely reporting of data. Mentor others in the use of MODA and other department software. Provide scientific recommendations and technical expertise for new instrumentation and methodology that may be introduced in the Microbiology department. Troubleshoot software errors for lab systems. Execute change controls as required by lab management. Provide scientific recommendations and technical expertise for new software and methodology that may be introduced in the Microbiology department. Support integration projects with other software into the MODA system. Perform other related duties as assigned. Knowledge, Skills & Abilities Extensive knowledge of computer usage for sample tracking, laboratory equipment, raw data handling and storage. Proficient in cGMP guidelines. Proficient with MS Word, Excel and PowerPoint Knowledge of database design and maintenance. Extensive experience in computer use/troubleshooting. Project Management and coordination experience. Effective written and oral communication skills. Ability to work independently and with a team. Core Values The Sr Microbiology Information and Data Specialist is expected to operate within the framework of Tolmar's Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each oth r and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task. Education & Experience Bachelor's degree in computer science or scientific discipline. 6 or more years of experience in pharmaceutical Microbiology or analytical laboratory position. Experience in Microbiological testing data of drug substances and formulations. Experience in Computer Systems and programming gained through formal academic studies or work experience. Working Conditions Laboratory and office setting. May be exposed to solvents, biohazardous materials and pharmaceuticals. Ability to work onsite as needed and could involve frequent travel if living outside of Colorado. Compensation and Benefits Annual pay range $115,000 - $125,000 Bonus eligible Benefits information:https://www.tolmar.com/careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.