Kelly Services
Location
Princeton, NJ | United States
Job description
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 Specialist
Location: Princeton, NJ
Duration: 6 months +
Responsibilities
Work in collaboration with process owner to update corporate documents (policies and procedures).
Ensure that the changes are processed in the Electronic Document Management system in compliance with internal procedural requirements.
Responsible for facilitation 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.
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 preferred
Proficiency in training management and product lifecycle management (Agile) systems preferred
Additional Information
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone ([email protected] ([email protected]) ) 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 ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Job tags
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