Responsibilities
• 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 the areas of Manufacturing, Packaging, Labeling and Holding Operations for Dietary Supplements.
• Manages all aspects related to 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 the development and implementation of GMP training program and conducts GMP training sessions when applicable.
• Maintains training programs documentation.
Requirements:
• Must have a Highschool Diploma, BS or BA degree preferred, or more than 3 years of experience in Regulatory Affairs, preferably in a pharmaceutical or related industry, or combination of education, experience, and/or professional training.
• Must have completed cGMP training and orientation programs successfully, 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 which include knowledge of MS office systems, as well as other ERP systems
Allendale NJ USA

Salary Criteria