Technical Writer III

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