Document Control Specialist (Quality Assurance) Position Available In Miami-Dade, Florida

Document Control Specialist (Quality Assurance) Llorens Pharmaceutical International Division, Inc. 7080 NW 37th Court, Miami, FL 33147

Position Overview:

Llorens Pharmaceuticals is seeking a detail-oriented Document Control Specialist to join our Quality Assurance team at our manufacturing facility in Hialeah, FL. The selected candidate will be responsible for managing and maintaining all quality-related documentation to ensure compliance with FDA, cGMP, and other regulatory requirements. This role is critical to maintaining the integrity of our documentation system throughout the lifecycle of our products—from raw material intake to finished goods.

Key Responsibilities:

Document Control & Records Management Maintain and organize controlled documents including SOPs, Batch Production Records, specifications, and validation protocols. Ensure all documentation is accurate, up to date, and compliant with current regulatory and company standards. Distribute, archive, revise, and retire documents in accordance with internal procedures. Monitor and enforce document version control, approval workflows, and access control. Coordinate document issuance for production and QA use. Batch Record & Quality Review Support Review completed Batch Production Records for completeness and compliance before final QA release. Assist QA team in compiling and organizing test results, validation records, and supporting documentation. Ensure timely reconciliation of documentation for production and quality events. Compliance & Training Support Ensure that all controlled documents reflect current regulatory guidelines and quality standards. Support the coordination and documentation of cGMP training activities. Assist with internal audits by ensuring availability and traceability of required records. Process Improvement & Support Recommend improvements to document control procedures and quality systems. Assist with drafting and revising SOPs in collaboration with QA and other departments. Support QA Manager and team with general administrative and compliance-related tasks.

Qualifications:

Education:

Associate’s or Bachelor’s degree preferred, especially in a science-related or technical field.

Experience:

Minimum of 2 years of experience in document control, quality assurance, or related role in a pharmaceutical, supplement, or regulated manufacturing environment.

Knowledge, Skills, and Abilities:

Must be fully bilingual (English & Spanish) Familiarity with FDA regulations and current Good Manufacturing Practices (cGMP). Proficiency with Microsoft Office (Word, Excel, Outlook). Experience with electronic document management systems (EDMS) is a plus. Strong organizational and communication skills. Excellent attention to detail and a commitment to accuracy and compliance. Ability to manage multiple tasks while maintaining a high level of quality.

Job Type:

Full-time Pay:

$16.00 – $22.00 per hour

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Schedule:

8 hour shift

Experience:

Quality Assurance:

2 years (Required)

Language:

English (Required) Ability to

Commute:

Miami, FL 33147 (Required)

Work Location:

In person