Summary: Seeking a Labeling/QA Specialist with experience in CAPA management, root cause analysis and process development to review and create labeling for medical products.

Requirements:

Previous experience in CAPA management/support

Experience in Root Cause Analysis

Familiarity with Process analysis/development

Ability to create, review, and reproduce text required for labeling medical products

Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements

Ability to monitor changes in labeling regulations in the US and/or abroad

Reviews promotional and commercial communication material ensuring consistency with the application

Monitor, evaluate and recommend improvements to labeling processes, quality systems tools or policies

Preferred Skills:

Bachelor's degree

1-2 years of relevant experience

Responsibilities:

Creating and reviewing text required for labeling medical products

Ensuring all produced materials meet legal and regulatory requirements

Monitoring changes in US or international labeling regulations

Reviewing promotional material to ensure its consistency with data application

Recommending improvements to the existing processes of labeling.

 

 

 

 

Pay Details: $27.00 to $36.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.