Title: Labeling Specialist
Location: US-Maryland-Baltimore
Job Number: REG0007G
The Labeling Specialist is responsible for developing, revising and implementing new and revised packaging and labeling for products marketed by BDDS. This function includes developing and maintaining content and graphic standards as proposed by Corporate, Regulatory and Global guidelines. The Labeling Specialist will act as the liaison between Labeling Design and Development and the plants serviced by BDDS to lead or participate in special projects on behalf of the Labeling Design and Development group. Additional responsibilities include supporting the Graphic Specialists and the Translation Specialist, providing technical literature support for the Sales and Marketing departments and assisting with the technical review of field communications and internal/external documents submitted through the Sales and Marketing, R&D and Technical Services approval systems. Works with minimal supervision, with status reports to the department manager.
Responsibilities
* Develops, revises and reviews product package labeling (carton labels, component labels, package inserts and user's manuals) to assure compliance/conformity with existing Corporate, Regulatory and Global (ISO, PAL, etc.) guidelines.
* For instrument user's manuals, studies and reviews manufacturers' data, drawings, parts lists and prototypes to delineate technology, operating procedure and specific logistics of operation.
* Works with R&D, Marketing, Quality, Medical, Regulatory and Plant production teams and associates to develop/revise product labeling and determine specifications for: type style, font size, clarity and conformity of wording, formatting and print paper.
* Assists with the development and implementation of packaging and labeling processes for plants serviced by BDDS.
* Works with Label Control, Incoming Inspection, Operations and Quality to resolve quality issues regarding labeling, and developing internal and external procedures geared toward minimizing and eliminating labeling recalls.
* Assists with the acquisition and implementation of translations.
* Develops and reviews vendor specifications for labeling.
* Develops and maintains graphic and label standards.
* Participates in the GPDS product development process.
* Develops procedures and policies to streamline the labeling design/development process.
* Assists with the development and publication of the LabO newsletter, Difco & BBL Manual and the QC/PI Manual.
* Assures the accuracy of field and internal/external documents by review of documents circulated through the approval systems of the Sales and Marketing, R&D and Technical Services Departments.
* Monitors the proper use of trademarks.
* Responsible for the implementation and completion of assigned projects within established time frames.
* Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business units and plant projects to meet established goals.
* Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements; participates as required in training on regulatory issues affecting own area of work; brings regulatory compliance questions/issues to the attention of management.
* Participates in the activities of professional and trade organizations through attendance at meetings.
* Administration of other policies and programs as may be determined to be within the purview of the Labeling Design and Development Department.
Qualifications:
* Bachelor's degree preferably in microbiology, molecular diagnostics or related field.
* Minimum of three years experience in clinical microbiology, in vitro diagnostics, healthcare, labeling/packaging development or technical writing; or equivalent combination of related education and experience.
* Ability to lead and participate in group projects, develop timelines for projects, communicate effectively and implement projects.
* Knowledge of Corporate, Regulatory and Global (ISO, PAL, etc.) guidelines pertinent to product/package labeling.
* Ability to handle multiple projects with excellent follow-up skills.
* Must have a functional knowledge of Microsoft Office Suite (MS Word, MS Excel).
* Must be detail-oriented and have the ability to work under deadline pressure; must be able to deal with unresolved situations, frequent changes, delays, or unexpected events.
* Must have ability to perform spreadsheet and database maintenance for reporting the status of projects to management.
* Must have good interpersonal skills, including effective written and oral communication ability.
* Experience or demonstrated proficiency in technical writing and editing.
* Accountable for the professional representation of BD as carried out by the Regulatory Compliance Department.
* Knowledge and experience in DTP software applications (InDesign, Framemaker and Illustrator) and label printing technology desirable.
* Healthcare industry and microbiology background desirable.
* Foreign language skills highly desirable.
Job: Regulatory Compliance