GMP Document Control Specialist

ALOIS Solutions; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

ALOIS Solutions is seeking a detail-oriented professional to manage quality documentation in a GMP environment. The role focuses on controlling SOPs, batch records, change orders, and validation documents, ensuring proper archiving and compliance across all documentation.

Responsibilities include maintaining document libraries and logs, supporting Change Control and Validation processes, and ensuring adherence to cGMPs and quality requirements in a fast-paced production setting.

Qualifications

• Associate degree with 1 year relevant experience, or high school diploma with 3+ years GMP quality/production experience.
• Strong attention to detail, communication, and organizational skills.
• Experience with SOPs, batch records, change orders, and document control in GMP/cGMP environments.

Responsibilities

• Manage SOPs, Work Instructions, Batch Records, Change Orders, and validation documents.
• Review, route, implement, and archive controlled documentation.
• Maintain document libraries, logbooks, and records.
• Support Change Control, Validation, and document management processes.
• Ensure compliance with cGMPs, SOPs, and quality requirements.

Skills

Quality Documentation

Document Control

cGMP

SOPs

Attention to detail

Communication

Organizational skills

Education

Associate Degree +1 year experience

High School Diploma +3+ years GMP

Job description

ALOIS Solutions is seeking a detail-oriented professional to manage quality documentation in a GMP environment. The role focuses on controlling SOPs, batch records, change orders, and validation documents, ensuring proper archiving and compliance across all documentation.

Responsibilities include maintaining document libraries and logs, supporting Change Control and Validation processes, and ensuring adherence to cGMPs and quality requirements in a fast-paced production setting.