Document Control Specialist

PrideStaff on behalf of a client in Oakland Park is seeking a detail-oriented and organized Document Control Specialist to join their Production Team.

Responsibilities

• Administers the Engineering Change Order (ECO) and Document Change Request (DCR) workflows from initial submission through final approval and implementation.

• Formats, proofreads, and standardizes incoming technical files, Standard Operating Procedures (SOPs), Device Master Records (DMR), and validation documents to ensure compliance with corporate style guidelines.

• Ensures strict version control across physical archives and electronic document management systems (eDMS), preventing the use of obsolete procedures on the manufacturing floor.

• Serves as a primary document scribe and retrieval specialist during internal, FDA, ISO, and customer quality audits.

• Performs routine internal record reconciliations, archiving, and periodic document reviews to ensure a constant state-of-readiness.

• Manages user permissions, folder structures, and access controls within the electronic Quality Management System (eQMS).

• Assists cross-functional team members (Engineering, Operations, Supply Chain) with document authoring workflows and eQMS navigation.

• Tracks and reports key performance metrics (KPIs), such as document approval cycle times, upcoming document review dates, and pending change requests.

• Issues controlled production batch records, device history records (DHR), and shop floor routing cards to manufacturing teams.

• Archives executed records upon batch completion, checking for completeness, missing signatures, or data gaps.

• Maintains a bulletproof document management infrastructure that guarantees audit readiness and compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP guidelines.

Qualifications

• Associate’s degree in Business, Information Management, Life Sciences, or equivalent practical experience required; Bachelor’s degree in a technical or business discipline is a plus.

• 3+ years of document control or quality administration experience within a regulated industry (Medical Device, Biotechnology, Pharmaceuticals, or Aerospace) required.

• Solid baseline understanding of cGMP, FDA Quality System Regulations (21 CFR Part 820), and ISO 13485 standards required; knowledge of 21 CFR Part 11 requirements regarding electronic signatures/records is a plus.

• Hands-on experience operating within enterprise eQMS/eDMS platforms (e.g., MasterControl, Veeva Vault, Arena, QT9, or Qualio) and advanced proficiency in Microsoft Office (Word formatting, Excel metrics) required.

• Certified Document Controller (CDC) or ASQ certification is a plus.

• Must be able to submit to a background check and a drug screen.

PrideStaff is an equal opportunity employer.

Compensation / Pay Rate (Up to): $16.00 - $17.00 Per Hour