GMP Manufacturing Documentation & ECO Specialist

QRC Group; Cayey (PR); On-site; USD 45,000 - 65,000; Full time

Job summary

QRC Group in Cayey, Puerto Rico is seeking a Manufacturing Support Specialist to manage controlled documentation and coordinate Engineering Change Orders (ECOs) within a regulated FDA/ISO environment.

You will create, format, revise, and maintain SOPs and batch records, ensure timely updates for capital projects, validation, QN and CAPAs, and support CI initiatives. Strong attention to detail, organizational skills, and proficiency with Microsoft Office are essential.

Qualifications

• Associate degree or equivalent is required.
• Minimum of 2 years of experience in documentation control in FDA/ISO regulated environment.
• Experience with GMP documentation such as SOPs, batch records, and change control.
• Proficiency with Microsoft Office and document control software.

Responsibilities

• Support implementation of document changes through ECO systems.
• Ensure updates related to capital projects, validation activities, Quality Notifications, and CAPAs are completed on time.
• Create, format, revise, and maintain SOPs, manufacturing batch records, and other GMP documentation.
• Assist in manufacturing data collection, reporting, and performance metrics tracking.
• Participate in Continuous Improvement (CI) and Lean Manufacturing initiatives.
• Support document control activities, including deviation records and periodic document reviews.

Skills

Attention to detail

Organizational skills

Time-management

Communication skills

Independent work style

MS Office (Word, Excel, PowerPoint)

Education

Associate degree or equivalent

Tools

Documentation Control Systems

Electronic Document Management System

Job description

QRC Group in Cayey, Puerto Rico is seeking a Manufacturing Support Specialist to manage controlled documentation and coordinate Engineering Change Orders (ECOs) within a regulated FDA/ISO environment.

You will create, format, revise, and maintain SOPs and batch records, ensure timely updates for capital projects, validation, QN and CAPAs, and support CI initiatives. Strong attention to detail, organizational skills, and proficiency with Microsoft Office are essential.