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