Document Control Specialist

Position Title : LOGISTICS- Document Control Specialist

Location : Garland, TX 75238

Shift : 1st Shift | 7 : 00 AM – 3 : 30 PM

Position Type : Contract-to-Hire

Classification : Hourly, Non-Exempt

Department : Quality Management

Reports To : Director of Quality Management

General Description

Essential Duties & Responsibilities

Write, revise, issue, and maintain QA documentation including SOPs, Work Instructions, Forms, Technical Files, Master Manufacturing Records (MMRs), Master Packaging Records (MPRs), Batch Records, Specifications, and other cGMP-related documents.

Coordinate and manage the change control process.

Identify process improvement opportunities related to efficiency and quality; implement updates through approved change control procedures.

Collaborate with subject matter experts to develop and improve SOPs.

Assist Quality Management with establishing, implementing, and maintaining the Quality Management System (QMS).

Serve as document control software administrator, managing document numbers, content types, user access, and user groups.

Additional Responsibilities

Assist with improvements to document management systems.

Provide documentation (hard copy or electronic) for regulatory inspections and internal / external audits.

Generate and maintain document status reports.

Competencies

Strong collaboration and interpersonal skills

Excellent organizational and time management skills

High attention to detail

Initiative and learning orientation

Qualifications & Required Skills

Ability to read, write, and speak English proficiently.

Experience navigating document control systems.

Knowledge of technical writing, process documentation, and document design.

Knowledge of basic office procedures and equipment.

Ability to follow and promote workplace safety practices.

Education & Experience

Bachelor’s degree required OR minimum of 3 years of experience in a Quality Management role.

Experience with Ensur (or similar document control software) preferred.

Physical Requirements

Ability to lift up to 15 lbs.

Ability to sit or stand for extended periods (4 hours).