Specification/Label Editor I

Responsible for compliant change control of documentation and labeling including new and revised procedures, department SOPs, manufacturing specifications and domestic labeling artwork, outside contract and third party manufactured product. Responsibility includes day to day authority to develop, annotate, format, review and approve documentation and labeling. This position is responsible for the timely approval and release of specifications and labeling artwork in accordance with project milestones and customer requirements under the direct supervision of the section manager.

Receives general direction daily from specification/label editor.

Priorities and projects are assigned by the section manager.

Meet deadlines set by agencies

Perform activities related to creation of new and revisions to existing product labeling, manufacturing specifications, test methods, corporate procedures and department SOPs as well as abiding by change control processes to ensure that revisions made are in compliance with domestic regulatory regulations, business and customer expectations, and are properly justified and approved by accountable functional areas and are issued in a timely manner to support production schedules.

Resolve daily issues inherent to domestic product documentation and labeling.

Serve as the primary contact for day to day customer inquiries regarding domestic/international documentation and labeling change status, procedure and format.

Demonstrate financial fitness of documentation and labeling changes to minimize potential destruction by working with the plants and materials management on formulation of an implementation plan using best practices

Manage multiple assignments and meet all required timelines.

Demonstrate proficiency on SAP DMS Document Management System.

One to two years’ experience in a technical, quality or operations area

Knowledge and familiarity with processing and testing of pharmaceutical products.

Knowledge of industry documentation, labeling and/or change control procedures.

Familiarity of graphics development and operations.

Plans, organizes and monitors workflow.

Prioritizes projects to ensure timely completion

Documentation and labeling control practices must be completed accurately, on time and per business, customer, and domestic agency regulations and requirements.

Quality of the product is directly linked to the accuracy of the documentation and labeling content.

Inaccurate documentation and labeling can delay product approval and launch or cause product quality issues in the field, potentially resulting in field actions and/or recalls.

Sneha

862-579-4236