Qualifications:
Background: • BS or MS degree in arts or sciences
• 4+ years of technical writing experience
• Experience in change management
• Experience in medical, pharmaceutical, or other FDA regulated environment
• Understanding of CAPA and Quality process
• Strong knowledge of the English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Knowledge of computer hardware and software, including Microsoft Office, Visio, Adobe Acrobat applications.
• Communicating effectively in writing as appropriate to the audience.
• Strong prioritization and multitasking skills. Managing one's own time and the time of others.
Responsibilities:
• Manage the documentation, change order, and change control processes
• Experience with computer based change management software. Write change plans, document change orders
• Maintain records and files of work and revisions
• Develop SOPs and associated technical documentation as required
• Interview and build relationships with SMEs in cross functional groups, including walking down a process to insure completeness and verify correctness
• Edit, standardize, or make changes to material prepared by SMEs or other Company personnel
• Manage new documentation and revised documentation through lifecycle and document management system
• Help with investigations, non-conformances and CAPA process
• Confer with customer representatives, vendors, regulatory personnel, or others to establish technical specifications
• Review established documentation and recommend revisions or changes in scope, format, and content
• Spend time with SMEs observing production, developmental, and experimental activities to determine operating procedure and detail.
• Develop specific goals and plans to prioritize, organize, and accomplish your work.
Regards,
Sweta Verma
IT Recruiter
Integrated Resources, Inc.
Inc. 5000 – 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
(Direct) 732 549 5907 | (W) 732 -549 - 2030 x 210| (F) (732) 549 5549
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.