Noramtec Consultants Americas Hiring for Labeling Assurance Specialist – JBR at Remote Full Time

Our client is a world leader in medical device development and manufacturing. This location focuses on research and assembly of said devices while also serving as their corporate headquarters. Encompassing 41 different medical specialties, few competitors can compete with our client’s experience and expertise.

Must Have:

EnLabel IPM software experience and label design

Labeling Assurance Specialist

Primary Function:

The Labeling Assurance Specialist will design, typeset, proofread, and coordinate the development of labeling materials, specifically for patient guides, physician manuals, additional labels, and instructions for use. This position will interact with other departments to assure labeling is in compliance with regulations and company policies.

Essential Job Duties:

– Collection of labeling content requirements from design team.

– Design of labeling materials (instruction for use, patient guides, additional labels) in the graphic design software to produce labeling materials that conform to pre-determined sizes and standards.

– Proof of various documents against source files to ensure accuracy.

– Management of multiple files through the process of review, approval, translation, and printing while maintaining strict version control.

– Collaboration with Labeling Assurance team members in order to provide status of labeling-related project deliverables.

– Update Labeling Assurance team members and design team to ensure labeling-related project deadlines are met.

– Review of upcoming labeling design changes to anticipate project load.

– Compile version history of instruction for use for legal, audit support, and internal request.

– Advise design team of internal Instruction for Use requirements.

– Compile list of products associated with specific instruction for use for internal request.

– Communicate with outside vendors to answer questions and ensure adherence to project schedules.

– Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

-Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

– Must work and interact effectively and professionally with and for others throughout various levels of the global organization.

– Must strictly adhere to safety requirements.

– Maintain regular and punctual attendance.

– Must maintain company quality and quantity standards.

– Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with

minimal supervision.

– Ability to remain calm and receptive in fast paced situations.

Work Experience/Education Requirements:

– High school diploma or GED.

– Minimum 5 years graphic design and typesetting experience in regulatory controlled industry.

– Proficient in Microsoft Word/Excel/Project/Outlook, knowledge of JBase

Physical Requirements/Work Environment:

– Works under general office environment conditions.

– Utilizes close visual acuity for working with computers and equipment.

– Frequently required to sit, stand, walk, and communicate.

Employees are eligible for the following benefits:

• Dental

• Vision

• Health

• 401K

We thank all candidates for their application, however only those that qualify will be contacted.

ROC1

Job Types: Full-time, Contract

Salary: Up to $60.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• High school or equivalent (Required)

Experience:

• Microsoft Word: 2 years (Required)
• Microsoft Excel: 2 years (Required)
• Labeling Design (Med Device or Pharma preferred): 2 years (Preferred)
• EnLabel IPM software: 2 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: Remote