Documentation Clerk

Full Time Tamarac, FL, US

Ennovi is an equal opportunity employer in conformance with all applicable laws and regulations to individuals who are qualified to perform job requirements. The Company administers its personnel policies, programs, and practices in a non‑discriminatory manner in all aspects of the employment relationship, including recruitment, hiring, work assignment, promotion, transfer, termination, wage and salary administration, and selection for training.

A Document Clerk in a medical component manufacturing company is responsible for managing, organizing, and maintaining the organization’s critical documentation in compliance with strict regulatory and quality standards. This role supports quality, regulatory, and operational processes by ensuring that all records are accurate, accessible, and up to date.

Core Purpose The document clerk ensures that all controlled documents — such as Standard Operating Procedures (SOPs), batch records, validation protocols, and regulatory submissions — are properly versioned, stored, and retrievable. The role is essential for maintaining compliance with FDA, cGMP, and ISO requirements, and for supporting audits, inspections, and quality monitoring.

• Partner with Quality Assurance and Document Control teams to manage controlled documents.
• Maintain electronic and physical document control systems, ensuring proper versioning, access, and security.
• Receive, log, and organize all incoming and outgoing documentation related to production, quality, and regulatory processes.
• Prepare, review, and distribute controlled documents, including SOPs, batch records, and validation protocols.
• Support audits and inspections by providing accurate and timely retrieval of documentation.
• Track document revisions, approvals, and expiration dates to keep records current.
• Coordinate with cross‑functional teams to facilitate timely submission, review, and approval of documents.
• Generate reports and metrics to support management oversight and quality monitoring.
• Ensure strict compliance with company policies, cGMP, FDA, and ISO requirements.

• Associate’s degree or higher in Life Sciences, Business Administration, or a related field.
• 2–5 years of experience in document control or clerical support in a regulated pharmaceutical or biotech environment.
• Knowledge of cGMP, FDA, and ISO documentation standards.
• Proficiency with electronic quality Management Systems (eQMS) and Microsoft Office Suite.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast‑paced environment.
• Preferred:
  Experience with eDMS platforms like QT9, Veeva Vault or Master Control, exposure to regulatory submissions, validation documentation, or quality audits.