Documentation Specialist - Digital Operations

QRC Group, LLC • Cayey, PR

10d

About The Position

We are seeking a Documentation Specialist for Digital Operations to support manufacturing documentation activities including processes supported by the Tulip platform. This role is responsible for developing, reviewing, and maintaining controlled documents that support compliance, traceability, and operational excellence in a regulated manufacturing environment.

Requirements

• Bachelor’s degree in science, engineering, quality, or related technical field.
• Experience in regulated manufacturing environments such as pharmaceutical, biotechnology, or medical devices.
• Working knowledge of GMP/GxP requirements, document control practices, and data integrity principles such as ALCOA+.
• Strong attention to detail, technical writing skills, and the ability to work cross-functionally with multiple departments.

Nice To Haves

• Experience supporting digital manufacturing systems or electronic documentation platforms are preferred.

Responsibilities

• Develop, review, and maintain manufacturing and digital documentation, including SOPs, digital work instructions, work instructions, batch records, and equipment maintenance logs.
• Ensure documentation is current, accurate, properly controlled, and aligned with regulatory requirements, GMP/GxP standards, internal quality procedures, and approved digital workflows.
• Support the creation and maintenance of controlled documents for product specifications, testing protocols, design history files, and digitized manufacturing processes.
• Maintain compliance with data integrity principles such as ALCOA+ and internal quality standards, ensuring traceability between approved documents and digital execution tools.
• Partner with Quality Assurance, Manufacturing, Engineering, and Digital Operations teams to ensure documentation and workflows meet company policies and industry regulations.
• Assist with internal audits, document reviews, and inspection readiness activities by providing documentation support and traceability evidence aligned with regulatory and ISO standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level