Job Description
Job DescriptionThis 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.
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