Newark Metro Area, NJ
1) Technical Writing Responsibilities:
a. Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation.
b. Responsible for routing documents through the Document Management system.
c. Write Deviations, CAPAs, Change Controls.
d. Facilitate periodic reviews of SOPs and provide subject matter expertise in documentation best practice.
Knowledge, Skills & Abilities:
Highly proficient computer skills in Microsoft Office Suite Word, Excel, "eQRMS" and Outlook with extensive background in database systems. Innate ability to learn new software.
Strong written and verbal communication skills. Highly proficient at writing well formulated emails and notifications.
Familiarity with FDA and EU environments and associated compliance regulations
Education & Experience:
AA / AS degree or acceptable combination of education and practical experience
Minimum 3 years experience as technical writer developing procedural documentation, interfacing with stakeholders to align different and potentially conflicting needs.