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Quality Document Control Specialist

Actalent, Irving, TX, United States


Quality Document Control Specialist (Entry Level)
Irving, TX | On-site

Position Summary
Seeking an entry-level Quality Document Control Specialist with 1–2 years of experience in medical device or pharmaceutical manufacturing. This role supports the manufacturing quality system by maintaining controlled documents and reviewing manufacturing and laboratory records in compliance with ISO 13485 and FDA regulations.

Key Responsibilities

Maintain, revise, and control quality documents (SOPs, forms, records)

Review manufacturing batch records, DHRs, and lab documentation for accuracy and compliance

Print, issue, and release controlled documents and lab test results

Ensure documentation meets ISO 13485 and GMP requirements

Identify documentation issues and escalated as needed

Support document control activities during audits and inspections

Required Qualifications

1–2 years of QA or Document Control experience in a regulated manufacturing environment

Experience in medical device or pharmaceutical manufacturing

Hands‑on experience with ISO 13485

Knowledge of GMP documentation practices

Experience with electronic document management systems for regulated manufacturing

Strong attention to detail and written/verbal communication skills

High school diploma required

Must pass color vision testing

Work Environment

On‑site manufacturing/laboratory setting

Monday–Friday business hours; occasional weekends may be required

Strict adherence to quality and safety standards

Job Type & Location
This is a Contract to Hire position based out of Irving, TX.

Pay and Benefits
The pay range for this position is $20.00 - $24.00/hr.

Medical, dental & vision

Critical Illness, Accident, and Hospital

401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long‑term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick Leave)

Benefits are subject to change and may be subject to specific elections, plan, or program terms.

Workplace Type
This is a fully onsite position in Irving, TX.

Actalent is an equal opportunity employer.

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