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Location

Princeton, NJ | United States

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Job description

A Documentation Specialist (hybrid) position in Princeton, NJ is now available through Adecco Medical and Science. In this role, you will be 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.

The work hours are Monday-Friday from 8:00am-5:00pm. This is a hybrid role, and you will be required to work three days onsite at the Princeton headquarters (Tuesday, Wednesday, Thursday).  You can work from home on Mondays and Fridays. This is a 40 hour/week, minimum 6-month temp/contract position starting in March 2024.  The pay rate is $28.00/hr.

Responsibilities :

• 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 the organizations’ 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.

Qualifications:

• A minimum of a Bachelor’s Degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline.
• A 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 is required.
• Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation, preferred.
• 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.) is required.
• Proficiency in training management and product lifecycle management (Agile) systems preferred.

Pay Details: $28.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

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Job tags

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Salary

$28 per hour