Intern, Laboratory Services at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Jul, 26

Salary

0.0

Posted On

04 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software validation, Technical writing, GMP compliance, FDA standards, ISO standards, SOP development, Data analysis, Project management, Communication, Interpersonal skills, Administrative tasks, Testing protocols, Quality assurance, Computer science, Laboratory operations

Industry

Medical Equipment Manufacturing

Description

Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary Performs a variety of project related tasks and functions associated with qualification, validation and implementation of software to be used by the Quality Laboratories. The intern shall understand the user needs of the laboratory and assist in customizing solutions to fit the GMP environment. Responsibilities Key Accountabilities Follows applicable SOPs, OSHA regulations and cGMP regulations. Technical writer for SOPs, Forms, attachments, and training and creation associated with applicable software Performs administrative tasks and duties, when applicable; including writing and reviewing case studies, writing and reviewing testing protocols, writing validation documents. Understands FDA and ISO standards applicable to the software and consequences of Nonconformance. Conducts themselves in a polite, helpful, and professional manner with all employees both inside and outside of the department. Assists with special projects and other duties as assigned. Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner. Interacts cooperatively with coworkers, supervisors or managers of other departments and receives direction well from superiors. Networking/Key relationships Manufacturing, Quality Ops, and IT Qualifications Minimum Knowledge & Experience required for the position: Currently enrolled in a Bachelor's degree ( BS/BA) program in Computer Science or a related field with a minimum of 3 years completed from an accredited four-year college or university; Strong verbal and written communication, interpersonal skills. Minimum of 3 years of previous college or university experience. Computer software implementation experience preferred Skills & Capabilities: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume. Ability to apply concepts of basic algebra and geometry. Ability to apply common sense understanding to carry out instructions furnished in written, oral and diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Travel requirements:N/A Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

The intern will perform project-related tasks associated with the qualification, validation, and implementation of software for Quality Laboratories. They will also assist in customizing solutions to meet GMP environment requirements and act as a technical writer for SOPs and validation documents.