GMP Documentation Specialist - Onsite 12-Month Contract

TekWissen LLC; Cincinnati (OH); On-site; USD 21,000 - 30,000; Full time

Job summary

TekWissen LLC is hiring a Manufacturing Documentation Associate for a 12-month onsite assignment in Cincinnati, OH. The role focuses on managing site batch records, cleaning records, and assembly sheets to keep GMP documentation accurate, organized, and accessible.

You will review docs for completeness, index and retrieve records, support audits, and coordinate with Manufacturing and Quality to ensure compliant records.

Qualifications

• High school diploma or equivalent required.
• Minimum of 1 year in administrative, clerical, records management, or document control.
• GMP, regulated manufacturing, or QA environment experience preferred.
• Familiar with batch records and records retention practices.
• Experience with SAP or similar ERP systems is highly desired.
• Strong attention to detail and documentation accuracy.
• Proficient in Microsoft Office and basic electronic document systems.

Responsibilities

• Receive, sort, organize, and maintain batch records, cleaning records, and assembly sheets per procedures.
• Review documentation for completeness, signatures, dates, sections, and attachments.
• Identify and launch missing or incomplete documentation per procedures.
• Index, file, and retrieve records using physical and electronic systems.
• Track document movement and maintain logs and database entries.
• Retrieve documentation for audits, inspections, and business requests.
• Support records retention, archiving, and disposition activities.
• Maintain organized filing systems and document inventories.
• Coordinate with Manufacturing, Quality, and admin teams to resolve issues.
• Ensure confidential information is handled appropriately.
• Perform general admin duties including data entry, scanning, and copying.

Skills

GMP documentation

Records management

Attention to detail

Cross-functional work

Documentation accuracy

Education

High School Diploma

Tools

SAP ERP

MS Office

Job description

TekWissen LLC is hiring a Manufacturing Documentation Associate for a 12-month onsite assignment in Cincinnati, OH. The role focuses on managing site batch records, cleaning records, and assembly sheets to keep GMP documentation accurate, organized, and accessible.

You will review docs for completeness, index and retrieve records, support audits, and coordinate with Manufacturing and Quality to ensure compliant records.