Bilingual Manufacturing Process & Quality Specialist

Inteldot; Juncos (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

Inteldot in Puerto Rico seeks an experienced Manufacturing Operations document control specialist to support QA GMP activities and process improvements. You will manage procedures, changes, validation activities, and training materials with minimal supervision.

The role emphasizes cGMP compliance, technical writing, and cross-functional collaboration with operations, quality, and regulatory teams. A bilingual Spanish/English professional is preferred.

Qualifications

• Experience handling controlled documentation in Veeva Vault or similar systems.
• Strong technical writing skills for procedures, reports and training materials.
• Proven ownership of change controls and related processes.
• Ability to manage projects and coordinate cross-functional activities.
• Familiarity with GMP, regulatory practices and documentation standards.
• Fluent in Spanish and English for regulatory and site communications.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and ensure currency.
• Triage non-conformances and support CAPA within established timelines.
• Author investigation reports and track corrective actions.
• Support process validation protocols, reports, and data collection.
• Monitor deviations and assist with root-cause analysis.
• Develop training materials and assist in delivering technical training.
• Assist with regulatory inspections and NPI documentation readiness.
• Coordinate with QA, Manufacturing, and Engineering to implement changes.

Skills

Veeva Vault (CDOCs)

Technical writing

Change control ownership

Project management

Smartsheet

Regulatory / GMP knowledge

cGMP compliance

Bilingual Spanish/English

Education

Doctorate or Master’s with 2+ years Manufacturing Ops exp

Bachelor’s with 4 years Manufacturing Ops exp

Associate’s with 8 years Manufacturing Ops exp

High school/GED with 10 years Manufacturing Ops exp

Tools

Veeva Vault

Smartsheet

Job description

Inteldot in Puerto Rico seeks an experienced Manufacturing Operations document control specialist to support QA GMP activities and process improvements. You will manage procedures, changes, validation activities, and training materials with minimal supervision.

The role emphasizes cGMP compliance, technical writing, and cross-functional collaboration with operations, quality, and regulatory teams. A bilingual Spanish/English professional is preferred.