Document Control Specialist (QA)

Description Document Control & Records Management Specialist I 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. 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