Documentation Specialist I_US
: Job Details :


Documentation Specialist I_US

MSCCN

Location: Princeton,NJ, USA

Date: 2024-12-12T22:08:07Z

Job Description:

Adecco Healthcare & Lifesciences is currently looking to hire a Documentation Specialist for their client in Princeton,NJ location . Job Title: Documention Specialist Shift Hours -8am to 5pm(M-F) Pay- 45.30/HR Job Type: 3months contract Job Summary: We are seeking a qualified Quality System Document Control Specialist to manage document control activities in compliance with U.S. and international regulations within the medical device or pharmaceutical industry. The ideal candidate will have a strong understanding of quality standards and a commitment to maintaining high-quality processes. Job and Competencies Requirements: Education: Minimum bachelor's degree in a relevant discipline (Science, Engineering, Mathematics, Computer Science, etc.). Experience: 1-3 years in the medical device/pharmaceutical industry. Knowledge: Required: Knowledge of QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards. Preferred: Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation. Skills: Strong oral and written communication skills. Effective interpersonal skills. Ability to multitask, prioritize, and meet deadlines. Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.). Preferred proficiency in training management and product lifecycle management (Agile) systems. Key Responsibilities: Facilitate quality system document control activities in compliance with FDA regulations, ISO standards, European Medical Device Directives, and other international regulations. Manage Document Change Orders for corporate quality system documents, including changes and training. Collaborate with document authors to release and implement Global Standard Operating Procedures (GSOPs). Participate in Change Review Board meetings. Operate within Integra's corporate document control and training systems to manage changes to quality system documents. Support quality system training and manage training requirements in the Learning Management System (LMS). Execute change orders in alignment with quality system priorities and the global QMS Roadmap. Engage in projects related to corporate document control activities. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. Pay Details: $40.00 to $45.30 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 To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance

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