Manufacturing Documentation Associatete

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

Position: Manufacturing Documentation Associate

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Monday to Friday from 08:00 AM to 05:00 PM

Pay Rate: $15 to $22 per hour

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Summary

The Manufacturing Documentation Associate / Office & GMP Records Clerk is responsible for managing site batch records, cleaning records, and assembly sheets to ensure GMP documentation is accurately maintained, organized, traceable, and readily accessible. This role supports document review, filing, records retention, and administrative processes while collaborating with Manufacturing, Quality, and other departments to ensure compliance with established procedures.

Responsibilities:

• Receive, sort, organize, and maintain batch records, cleaning records, and assembly sheets in accordance with approved procedures.
• Review documentation for completeness, including required signatures, dates, sections, and attachments.
• Identify and launch missing or incomplete documentation according to established procedures.
• Index, file, and retrieve records using physical and electronic document management systems.
• Track document movement between departments and maintain accurate records, logs, and database entries.
• Retrieve documentation for audits, inspections, and authorized business requests.
• Support records retention, archiving, and disposition activities in accordance with established procedures.
• Maintain organized filing systems, records storage areas, and document inventories.
• Coordinate with Manufacturing, Quality, and administrative teams to resolve documentation issues and support workflow efficiency.
• Ensure confidential and controlled information is handled appropriately.
• Perform general administrative duties, including data entry, scanning, copying, and document preparation.

Required Skills:

• High school diploma or equivalent required.
• Minimum of 1 year of administrative, clerical, records management, or document control experience is required.
• Experience in GMP, regulated manufacturing, laboratory, or Quality environments preferred.
• Familiarity with batch records, controlled documentation, and records retention practices preferred.
• Experience with SAP or similar ERP systems is highly desired.
• Experience organizing, indexing, filing, and retrieving records using structured filing systems.
• Strong attention to detail, organizational skills, and documentation accuracy.
• Proficiency in Microsoft Office applications and basic electronic document management systems.
• Strong written and verbal communication skills.
• Ability to follow written procedures, manage recurring tasks, and identify documentation discrepancies.
• Ability to work independently and collaborate effectively with cross-functional teams.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.