Document Control Analyst/ Labeling Specialist
Job Description:
Labeling Specialist to be part of a team responsible for the optimization of the product labeling processes and systems including data accuracy, template standardization, and compliance to the quality management system and regulatory standards. The position supports the investigation of label data discrepancies and facilitates label document updates to ensure compliance to all applicable standards. This position also requires a person who is detail-oriented, has the ability to manage multiple priorities, has exceptional organizational skills and is a self-starter with minimal supervision. Accustomed to working well under pressure and possess excellent problem-solving and communication skills.
Major Responsibilities:
Ensures labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.
Provide direct support for ongoing updates, including hazard communication, regulatory compliance projects, and other specialized projects
Initiates change orders for new and revised labels using the Electronic Documentation Management System and label change control software.
Identifies issues with label template design to promote standardization and optimization of the process.
Comply with document change control process and coordinates the initiation, approval, and completion of Change Orders, Change Requests, etc. as necessary
Utilizes multiple systems to gather data to support change orders to update bill of materials, batch records, and labels
Works closely with other team members to prioritize workload and coordinate data reviews and modifications
Utilizes lean methodology and problem-solving tools such as Gemba walks, kaizens, and RCCMs to support continuous improvement activities related to quality and efficiency of the label printing process
Presents timelines for project tasks and clearly communicate progress updates
Utilizes Excel for mass data analysis and uploads to Oracle (OCPLM) document management system
Participates in special projects and performs other duties as required
Experience:

• Entry Level role, prefer if they have experience
• Need someone with ability to learn fast.
• Needs to have problem solving experience
• Proficient in the use of Microsoft Office Software (Word, Power Point, Excel, etc.)
• Excel needs to be Moderate (pivot tables, vlookup, summaries, relationships, etc.)
• Aptitude for learning new technical software, such as quality management system
• Works independently on new and on-going assignments
• Is energized working in a fast-paced environment
• Detail oriented, consistent, dependable and accurate in carrying out responsibilities
• Displays positive attitude toward job and others
• Results-oriented and data driven
• Proactive approach that anticipates needs and problems while creating solutions
• Strong verbal and written communication skills
• Continuous improvement minded.
• Strong collaborative skills and the ability to influence others without authority
• A versatile skill set, that includes the ability to adjust to a dynamic department s needs