Bilingual Quality Assurance Regulatory Technician

Job Description

Job Description

REQUIRED QUALIFICATIONS

• Must have a high school diploma, preferably in a pharmaceutical or related industry, or a combination of education, experience, and/or professional training.
• Must be Bilingual English/Spanish
• Must have successfully completed cGMP training and orientation programs; the previous cGMP in relevant manufacturing fields is preferred.
• Must possess excellent technical writing and verbal communication skills.
• Must be able to handle multiple tasks and manage deadlines. 
• Must have strong computer skills, including knowledge of MS Office systems and other ERP systems.

 

ESSENTIAL FUNCTIONS

 

• Ensures that NFI established proper procedures, policies, and adequate cGMP controls to guarantee total compliance with the FDA Regulations stipulated in 21 CFR Part 111, in Manufacturing, Packaging, Labeling and Holding Operations for Dietary Supplements.
• Manages all aspects of accreditations, certifications, licenses, and permits from Federal and International governing agencies and third-party certifying agencies. 
• Determines regulatory compliance for all labeling & packaging components.
• Acts as Regulatory intelligence.
• Prepares customer quality questionnaires.
• Informs management of current development of FDA regulations and industry practices.
• Consolidates information from department managers to coordinate updating of procedures.
• Maintains inventory and ensures safe storage of all labels.
• Controls the issuance and return of labels from the packaging department.
• Coordinates developing and implementing the GMP training program and conducts GMP training sessions when applicable.
• Maintains training program documentation.
• Prepares technical submissions for International registration of Dietary Supplements.
• Reviews status and maintains currency of Trademarks, Registrations, and Patents as required; and
• Performs other duties as assigned by the immediate supervisor.