Reg Affairs Associate

Essential Functions And Responsibilities

• Develop, generate or edit controlled documents such as: Standard Operating Procedures (SOP), forms, raw materials and finished product specifications, methods for testing, validation reports, complaints, certificate of analysis templates, protocols, deviations, laboratory notebooks, and product monographs.
• Revise Master Formulas upon creation/revision.
• Control and distribute SOPs (new and revisions).
• Care for change control system and compliance.
• Prepare annual and refresher training material as per Training Matrix and coordinate annual GMP training.
• Coordinate audit schedules for Vendor Qualification purposes.
• Generate supplier audit reports and follow-ups.
• Handle Customer and regulatory audits as required by the Director of Quality or President.
• Generate CAPA reports to customer audits.
• Prepare regulatory documentation for submissions as required, including 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.
• Maintain 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
• 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