Laboratory IT Associate

This role will serve as a business representative for laboratory IT systems and will be responsible for mentoring laboratory personnel on the use of electronic lab systems as well as supporting internal and external audits as a laboratory IT system subject matter expert. Key Objectives/Deliverables Performs or supports Laboratory with the validation of laboratory equipment and software systems. Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the laboratory. Act as business owner and contact SME for QC laboratory IT systems. Responsible for collecting data and authoring periodic review documents for laboratory information systems. Provide oversight and support continuous improvement of quality systems as they relate to laboratory informatics. Apply knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices. Assist in improvement of quality systems by creating or revising worksheets, developing, or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems. Responsible for method management in the QC Laboratory, specific to scripted or coded methods. Supports and/or leads investigations, CAPA and change control initiatives. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations. Requirements (Education, Experience, Training) Bachelor’s degree in a computer science, life science, or applied science with at least five (5) years of demonstrated relevant experience in a GMP lab. Preferred attributes but not required Experience with computer systems including Microsoft Office suite, laboratory information management systems. Investigation and deviation management experience. Demonstrated proficiency in computer system validation. Experience with compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Strong oral and written communication skills and demonstrated through documentation and presentation skills. Demonstrated strong interpersonal interaction skills. #J-18808-Ljbffr