Manufacturing Systems Support Specialist

Manufacturing Systems Support Specialist

Country

United States

Shift

1st

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.

The Manufacturing Systems Support Specialist performs all activities associated with document review, document control, scanning, records management, ERP data entry, and electronic document maintenance at the Norcross facility. En-sures documentation is accurate, complete, and compliant with company procedures and regula-tory requirements. Responsible for scanning records and uploading documents to the designated drive while maintaining data integrity and supporting operational and quality processes.

This position is not eligible for sponsorship for work authorization by Werfen. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

• Review and verify documents for accuracy, completeness, and compliance.
• Enter, update, and maintain data in ERP system.
• Ensure documentation follows company procedures and regulatory requirements.
• Investigate and resolve documentation discrepancies.
• Maintain organized electronic and physical records.
• Scan all required records and upload documents to the designated electronic document repository/shared drive, ensuring accuracy, completeness, and accessibility.
• Follow GMP documents, including Standard Operating Procedures (SOPs) and Manufacturing Records, with strict adherence to quality, safety, and compliance requirements.
• Comply with OSHA safety regulations, including blood borne pathogen safety requirements.
• Support internal and external audits by retrieving and providing accurate documentation.
• Collaborate effectively with coworkers, supervisors, and cross-functional departments to support business and quality objectives.
• Demonstrate supportive behaviors toward coworkers and cooperate as an effective member of the team.
• Assist with special projects and other duties as assigned.
• Perform additional responsibilities that may not be specifically listed but are required to support departmental and business needs.
• Follow management direction, maintain professional workplace conduct, and uphold Werfen values at all times.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Maintain effective working relationships with cross-functional departments to support production, compliance, and customer requirements.

  Communicate documentation issues, corrections, and updates across departments to facilitate timely resolution and continuous improvement.

• Associate degree or equivalent from an accredited two-year college or technical school, or an equivalent combination of education, training, and related experience.
• Proficiency in Microsoft Office Suite, including Word, Excel, and Outlook, with the ability to effectively use these applications for daily administrative and operational tasks.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.