Inova Diagnostics

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

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.

Manufacturing Systems Support Specialist

Responsibilities

Key Accountabilities

• 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 bloodborne 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.

Networking/Key relationships

• 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.

Manufacturing Systems Support Specialist

Qualifications

Minimum Knowledge & Experience required for the position:

• 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.

Skills & Capabilities:

• Ability to read and interpret documents such as safety rules, operating instructions, maintenance instructions, Standard Operating Procedures (SOPs), and procedure manuals.
• Ability to write routine reports, business correspondence, and documentation accurately and professionally.
• Ability to calculate figures and amounts such as percentages, proportions, discounts, and other basic mathematical calculations as required.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, and diagram form.
• Ability to identify, investigate, and resolve documentation discrepancies.
• Proficiency in ERP system data entry and document management processes.
• Ability to maintain accurate records and ensure data integrity.
• Strong organizational, communication, and teamwork skills.
• Ability to adapt to changing priorities and perform multiple tasks in a fast-paced manufacturing environment.
• Ability to work irregular hours and days as necessary to meet production schedules and business requirements.

Travel requirements:

No travel is required for this role.

Manufacturing Systems Support Specialist (Manufacturing Production)

Closing

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