Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!Title: Documentation SpecialistLocation: Princeton, NJDuration: 4 months Pay Rate : $24.40 – $42.36/hour (DOE)Type: W2 contract (NO C2C OR THIRD PARTY)Responsibilities
Facilitation of quality system document control activities in compliance with U.S. and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations.
Facilitates Document Change Orders for corporate quality system documents including document changes and training.
Collaborates with document authors to release and implement of Global Standard Operating Procedures (GSOPs).
Participate to Change Review Board meetings.
Operate in Integra’s corporate document control and training systems to transact changes to quality system documents.
Support quality system training and management of quality system training requirements in LMS
Execute change orders in alignment with quality system priorities and the global QMS Roadmap
Participate to projects linked with corporate Doc Control activities.
Work in collaboration with process owner to update corporate documents (policies and procedures).
Make sure that the changes are processed in the Electronic Document Management system in compliance with internal procedural requirements.
Collaborate with the other team members to have the change reviewed and appropriate training
Required Qualifications
Bachelor’s degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline
Minimum of 1-3 years of overall experience in the medical device/pharmaceutical industry.
Demonstrated knowledge of QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards
Strong oral and written communication skills and effective interpersonal skills.
Ability to multitask, prioritize and meet deadlines.
Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.)
Preferred Qualifications
Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation
Proficiency in training management and product lifecycle management (Agile) systems
Additional Information
Hybrid: 3 days on site (Tuesday, Wednesday, Thursday)
Applicants must be legally permitted to work in the United States. Sponsorship is not available for this opportunity. OPT or H1B Visa is not being accepted at this time.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Please contact Taryn Carbone (taryn.carbone@kellyengineering.com (taryn.carbone@kellyservices.com) ) for immediate consideration.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 ® Engineering?Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.About KellyWork 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.
