Supervisor Document Control - Transfusion and Transplant

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 health-care professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary:

Develops, recommends and implements document control systems and processes to ensure effective compliance to Immucor's policies and external regulations. Establishes and implements procedures and policies needed to meet the demands of document control in a regulated medical device company. Responsible for/ supports the Document Control project management for global policies, change control and/or documentation initiatives. Ensure allocation of resources consistent with long and short term objectives. Train department management and staff in compliance with established systems.

Overseeing the controlled documentation processes within a medical device organization, ensuring all documentation is accurate, up-to-date, and compliant with relevant regulations and industry standards. This includes managing document control systems, ensuring secure access, and maintaining records. They also often lead and train document control technicians.

Key Accountabilities

• Responsible for overall coordination, maintenance and filing of Quality Operations, Regulatory Affairs/Compliance, Quality Systems, Research/Development and Laboratory operations documentation within the company, including manufacturing (DHR)and release records for distributed products.
• Ensure that all Quality System procedures and documents are maintained and controlled according to regulatory requirements and internal Standard Operating Procedures (SOPs).
• Develop, maintain, update and provide recommendations for improvements for the department overall systems used for the development, approval and management of the documents developed.
• Manage the development and approval of labeling and product specifications.
• Collect, analyze and present metrics data related to document control.
• Assist in supporting external audits, coordinating activities in backroom and ensuring timely response to documentation requests for auditors.
• Lead and motivate staff to develop and accomplish department goals and objectives. Ensure continued staff development in the technical and professional skills to optimize performance in their daily duties.
• Ensure maximum and efficient utilization of department budgetary resources. Provide recommendations and alternatives on systems and/or organizational improvements to facilitate cost reduction and/or maintain budget guidelines.
• 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

• Working with cross-functional teams at Norcross site including Operations, Research and development, Regulatory Affairs, Marketing, and Quality Assurance.

Minimum Knowledge & Experience required for the position:

Education:

• Associate Degree or higher preferred in Scientific field

Experience:

• 5 to 7 years of experience in the medical device, pharmaceutical, or biotechnology industry is highly preferred.
• 2 to 3 years of experience in a supervisory role in a scientific field preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Familiarity with electronic document management systems (EDMS) and quality management systems (QMS).
• The ability to manage multiple tasks and prioritize responsibilities effectively.
• Able to work in a team environment and collaborate
• Display PC skills with Microsoft Office (Word, Excel) and other desktop functions at an intermediate level.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience).

Travel Requirements:

• N/A

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