Job Description
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.
Position: Manufacturing Documentation Associate
Location: Cincinnati, OH, 45237
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Cincinnati, OH, 45237
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday From 08:00 AM to 05:00 PM
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 escalate 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.
- Business-level English proficiency required.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Cincinnati, OH |
| Industry | Computer/IT Services |
| Salary | $15–$22 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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