**Job Title:** Document Controller (Hybrid – GMP Manufacturing Support) **Location:** Parsippany, NJ (Hybrid: 4 days onsite, 1 day remote) **Employment Type:** Contract **Schedule Flexibility:** Must be available for early start times to support manufacturing shifts **Position Overview:** We are seeking a skilled **Document Controller** to support GMP manufacturing operations by managing the full lifecycle of GxP and non-GxP documentation. The ideal candidate will have **hands-on experience** with electronic document management systems (EDMS), particularly **Veeva Vault** , and be proficient in executing document control workflows from initiation to archival. This role is essential for maintaining documentation accuracy, regulatory compliance, and supporting cross-functional teams in a fast-paced, regulated manufacturing environment. **Key Responsibilities:** + Generate, issue, and track GMP-controlled documents (e.g., batch records, logbooks, worksheets, SOPs, forms) in both hard copy and digital formats. + Initiate and manage document workflows within **Veeva Vault** (or other EDMS), including routing for review, approval, and periodic review. + Ensure formatting standards and metadata accuracy throughout the document lifecycle. + Collaborate with authors, reviewers, and approvers to ensure timely and compliant documentation processes. + Digitize and archive hardcopy records per site procedures and regulatory requirements. + Monitor and maintain periodic review schedules for controlled documents. + Support the migration of documents from Qumas to Veeva, ensuring metadata integrity and version control. + Partner with manufacturing, quality, validation, and training teams to streamline documentation practices. + Support document formatting, revision, and change control in alignment with GMP and internal SOPs. + Maintain document retention and availability for audits and inspections. **Required Qualifications:** + Direct, hands-on experience in **document control** within a regulated (GMP/GxP) manufacturing environment. + Proficiency with **EDMS platforms** , especially **Veeva Vault** . + Demonstrated ability to manage full document **workflows, including initiation, review, approval, and periodic review processes.** + Strong attention to detail and understanding of documentation compliance standards. **Preferred Qualifications:** + Experience with additional EDMS platforms (e.g., Qumas, Documentum). + Background in life sciences, pharmaceuticals, or biotechnology. + Familiarity with documentation types beyond regulatory submissions, such as validation protocols, controlled forms, and annual product reviews (APRs). + Experience supporting documentation needs in active plant operations. 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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. 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