GMP QA Documentation Specialist (Batch Records)

Randstad USA; Melrose Park (IL); On-site; USD 28,000 - 34,000; Full time

Job summary

Randstad USA in Melrose Park, IL is seeking a QA Documentation Specialist for a full-time, on-site role. The contract is 3-months with potential extension based on performance. Responsibilities include issuing batch production records, maintaining EDMS, and ensuring GMP-compliant documentation.

The ideal candidate has experience in regulated documentation, strong Word skills, and a background in pharma/biotech or medical devices. On-site work Monday-Friday, 8:00 AM-5:00 PM.

Qualifications

• HHands-on experience managing regulated documentation within GMP-compliant environments.
• High proficiency in Microsoft Word for document editing, formatting, and template updates.
• Prior pharmaceutical, biotech, or medical device industry background.
• Direct experience operating EDMS, Documentum, TrackWise, or similar cloud documentation tools.
• Bachelor's degree (Associate's degree or High School Diploma with relevant experience accepted).
• Solid computer systems software navigation skills.
• Proven reliability, accountability, and strong self-management skills.

Responsibilities

• Issue 8 to 12 batch production records weekly to active packaging and manufacturing lines.
• Coordinate and review weekly production schedules to identify and issue required product records.
• Navigate and maintain cloud-based EDMS.
• Perform document editing, updates, and formatting in Microsoft Word for batch record revisions.
• Self-manage daily and weekly workflows independently to support continuous production output.

Skills

GMP

QA

Batch Record

Education

Bachelor's degree

Tools

EDMS

Documentum

TrackWise

Job description

Randstad USA in Melrose Park, IL is seeking a QA Documentation Specialist for a full-time, on-site role. The contract is 3-months with potential extension based on performance. Responsibilities include issuing batch production records, maintaining EDMS, and ensuring GMP-compliant documentation.

The ideal candidate has experience in regulated documentation, strong Word skills, and a background in pharma/biotech or medical devices. On-site work Monday-Friday, 8:00 AM-5:00 PM.