Label Specialist

General Position Summary

Label Specialist is responsible for assisting site-wide compliance of the activities related to Sakura Finetek USA (SFA) product labels. Label Specialist will assist generating, evaluating, and maintaining the product labels for product under development and/or production throughout the life cycle of the device. Will assist to ensure label creation, control and maintenance systems are running according to necessary specifications and operate within regulations.

Label Specialist facilitates product label creation and maintenance of the database. Assists with product label verification to ensure the new products meet the requirements as part of product launch, in addition to revise the existing product labels and follow through the approval process. He/she will also facilitate the label change control to qualify the label for quality of the print, integrity, legibility, and accuracy. Acts as a liaison between Software Engineer, Manufacturing and QC as part of the Label Control process for new and existing master product labels.

Essential Job Functions

Quality Support Activities

• Creates, updates and proofread existing graphical products and packaging labels
• Creates, updates and proofread data and graphical label design required to electronically generate product labels and packaging labels by Bartender software, creating and updating one primary and several secondary databases, and forms.

• Ability to learn and work with the following programs: Barcode Studio (generation of HIBC barcode), GS1 (generation of GTIN), Network drives and Dropbox (document repositories), Oracle Agile (submission and monitoring of documents).
• Ability learn and work with Microsoft Excel program for label contents database management.
• Ability to learn and work with Adobe Illustrator program for graphical labels and product label forms.
• Ability to create a label design or label dataset based on the information provided in the label request form (submitted by various department representative within the organization).
• Ability to make assessment for most suitable label from the existing forms considering product packaging.
• Ability to design a new label form from Bartender software as most adequate for a product packaging.
• Ability to design a new graphical label as most adequate for a product packing.
• Expands and rationalize labels to advance manufacturing efficiency.
• Adhere to all customer/company and cGMP procedures, along with safety regulations within the workplace.

• Facilitates the label control process internally (within the Sakura Finetek USA) and externally (with the OEM suppliers, producing finished goods for Sakura Finetek USA); maintains the Labeling Agreement documents, and assists with label qualification for quality of the print, integrity, legibility, and meeting the pre-determined specifications.
• Participates in the maintenance of ISO 13485 procedures and instructions.

• Performs other related duties as assigned by Sr. Director of Q.A. & Regulatory Affairs and leadership.
• Provide feedback by preparing charts, graphs, reports and other methods of communication as to how well the Quality System is working.
• Assist to provide inputs for communication with regulatory agencies regarding compliance documentation.
• Assist to initiate preventive action based on improvement opportunities or trends identified by the Sr. Director of Q.A. & Regulatory Affairs.
• Assist to initiate action items and assigns responsibilities.

• Under direction of the Sr. Director of Q.A. & Regulatory Affairs, follows up on resolution of quality issues.
• Recommends measures to improve product label and packaging label quality.
• Assist to evaluate the adequacy of quality systems and methods.
• Interact with individuals from different disciplines (Manufacturing, Quality, Engineering, R&D, Marketing, and IT) to plan, design, and execute label creation and maintenance.
• Support risk assessment exercises relative to product label and associated claims.

Essential Job Requirement

Education

• Associates Degree (AA) in a technical filed i.e., Science/Engineering (EE, ME, IE) from an accredited institution or equivalent combination of education and experience.

Experience & Minimum Qualifications

• Minimum of two years in a technical field experience with a minimum of one year in the data analysis process.
• Working knowledge in interpreting graphs, charts, diagrams, equipment guides and other instructions to solve problems.
• Working knowledge in writing plans, reports, procedures and project schedules.
• Experience in using scientific rules and methods to solve problems.
• Working knowledge in identifying complex problems and developing and evaluating options and implementation of solutions.
• Working knowledge of programing and coding capability is a plus.
• Working knowledge of FDA labeling requirements is a plus.
• Working knowledge of ISO standards; ISO 13485 is a plus.
• Working knowledge of EU regulations as it relates to medical device and IVD devices labels is a plus.
• Excellent computer skills with Microsoft office products.
• Experience with ERP systems is a plus.
• Experience with electronic documentation system a plus.
• Must demonstrate a high commitment to quality.
• Strength in organization, detail oriented, and ability to work in multi-task working conditions with minimal supervision.
• Must possess self-motivation, enthusiasm, and a positive attitude and perform as a team player.
• Strong written and verbal communication skills.
• Ability to get along well with diverse personalities. Must be tactful, mature and flexible.

Physical Requirements & Working Environment

• This position requires the employee to frequently sit. In addition, the employee is occasionally required to stand, walk, use hands and fingers and reach with hands and arms.
• Must be able to occasionally lift and/or move up to 15 pounds.
• Ability to read and analyze hard written copy and information on a computer screen.
• Ability to communicate verbally and respond to inquiries in person, over the phone, or in writing to individuals and groups.

"Sakura Finetek USA, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law."

The above description identifies the essential job functions and skills needed by the person or persons assigned to this position.These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.