Job Description
Job Description
Job Description
Document Control & Records Management Specialist I
Position Summary
Key Responsibilities
Qualifications
Preferred Experience
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
Location: Durham NC
Schedule: Monday–Friday, 8:00 AM – 5:00 PM
Pay Rate: $30–$40/hour (W2)
Contract Duration: 3 months (with potential for extension)
Position Summary
We are seeking a Specialist I, Document Control & Records Management to support the site’s documentation and record-keeping systems in accordance with cGMP and regulatory requirements. This role ensures controlled documents—including SOPs, batch records, and quality forms—are properly created, maintained, archived, and retrievable to support compliance across manufacturing, quality, and operations.
The ideal candidate will work cross-functionally with Manufacturing, Quality, Engineering, and other departments to maintain documentation standards and support audits, process improvements, and system training.
Key Responsibilities
Administer the document control and records management systems in compliance with FDA, EMA, ICH, and cGMP guidelines.
Process controlled documents through their lifecycle: creation, revision, approval, issuance, distribution, and archival.
Ensure all documents follow current formatting, content, and template standards.
Issue and reconcile batch production records and logbooks; maintain accurate archiving (electronic and physical).
Support document retrieval and record review during internal and external audits/inspections.
Facilitate periodic reviews to ensure documents remain current and effective.
Provide user support and basic training on document control systems (e.g., Veeva Vault, MasterControl, TrackWise, Documentum).
Identify opportunities for continuous improvement in document and records processes.
May assist with related quality system processes (e.g., Change Control, CAPA, Training).
Qualifications
Bachelor’s degree in a scientific, technical, or related field preferred; equivalent work experience considered.
Minimum 3 years of experience in document control or records management in a cGMP-regulated pharmaceutical, biotech, or medical device environment.
Proficient with electronic document management systems (e.g., Veeva Vault, MasterControl, Documentum).
Strong attention to detail and understanding of cGMP documentation best practices.
Effective communication and collaboration skills across departments.
Comfortable working in a fast-paced, regulated environment.
Proficient in Microsoft Office (Word, Excel, PowerPoint).
Preferred Experience
Prior experience supporting sterile or aseptic manufacturing.
Experience issuing and archiving executed batch records and logbooks.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
Numbers & Facts
| Location | Durham, NC |
| Industry | Staffing/Employment Agencies |
| Salary | $30–$40 Per Hour |
| Company Size | 10,000 employees or more |
| Year Founded | 1946 |
| Website | https://www.mykelly.com/ |
About Company
Finding great work for top talent.
Kelly helps companies recruit and manage skilled workers and helps job seekers find great work in industries such as accounting and finance, education, engineering, government, manufacturing and production, technology, and more.
Since inventing the staffing industry in 1946, we’ve become experts in the many specialties and local and global markets we serve. With a network of suppliers and partners around the world, we connect 450,000+ people with work every year. We ensure companies have the people they need, when and where they’re needed most.
Skills
- Artificial Intelligence (AI)unmatched
- Asepsisunmatched
- Best Practicesunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Detail Orientedunmatched
- Document Controlunmatched
- Document Managementunmatched
- Documentationunmatched
- Documentation Standardsunmatched
- External Auditunmatched
- FDA (Food and Drug Administration)unmatched
- Federal Governmentunmatched
- ICH Regulationsunmatched
- Internal Auditunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Medical Equipmentunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Process Control Engineeringunmatched
- Process Improvementunmatched
- Quality Assuranceunmatched
- Quality Engineeringunmatched
- Record Keepingunmatched
- Records Managementunmatched
- Regulatory Requirementsunmatched
- Standard Operating Procedures (SOP)unmatched
- Support Documentationunmatched
- Team Playerunmatched
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