Regulatory Affairs Associate

Essential Functions and Responsibilities:

• Responsible for developing, generating or editing controlled documents such as: Standard Operating Procedures ,SOP related Forms, raw materials and finished product specifications, methods for testing, validation reports, complaints, certificate of analysis templates, protocols, deviations, laboratory notebooks and Product monographs
• Responsible for the revision of Master Formulas upon creation/revision
• Responsible for control and distribution of SOPs (new and revisions)
• Coordinates change control system and compliance
• Prepares annual and refresher training material as per Training Matrix and coordinates annual GMP training.
• Coordinates audit schedules for Vendor Qualification purposes.
• Generates supplier audit reports and follow ups.
• Handles Customer and regulatory audits as required by the Director of Quality or President.
• Responsible for generating CAPA reports to customer audits.
• Prepares regulatory documentation for submissions as required.
• Responsibilities include document review to ensure accuracy, secure storage, efficient access to technical documentation for review or updating and maintenance of Documentation files/databases to ensure data accuracy
• Monitors processing status, location, secure hard copy master files, document searches, copies and archival
• Coordinates adherence to cGMPs and company SOPs, policies and records with area supervisors.
• Perform other duties as assigned by the immediate Supervisor.

Qualifications:

• Bachelor’s degree in Science or equivalent work experience or a combination of both.
• 1 - 3 years’ experience
• Bilingual (English and Spanish) preferred
• Knowledge in GMP regulations
• Computer literate
• Detailed oriented
• Previous experience working in production or QC preferred