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Reg Affairs Associate

Arnet Pharmaceutical

Fort Lauderdale, FL

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JOB DETAILS
SKILLS
Analysis Skills, Change Control, Computer Skills, Control Systems, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Quality, Detail Oriented, Distribution Control, Document Management, Documentation, Documentation Review, Editing, English Language, File Maintenance, GMP (Good Manufacturing Practices), Laboratory Notebook, Multilingual, Photocopy, Quality Assurance Methodology, Quality Control, Records Management, Regulations, Reporting Skills, Spanish Language, Standard Operating Procedures (SOP), Technical Writing, Validation Testing, Vendor/Supplier Evaluation, Vendor/Supplier Planning
LOCATION
Fort Lauderdale, FL
POSTED
1 day ago
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

About the Company

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Arnet Pharmaceutical

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