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.