Job Seekers, Please send resumes to resumes@hireitpeople.com Primary Skills: 4 - 6 years of experience as a Technical Writer in the biotechnology /pharmaceutical 
Description:-

Client is seeking a strong Technical Writer to focus on writing SOPs for lab systems. 

The candidate must possess the following: 
• Excellent attention to detail 
• At least 4 - 6 years of experience as a Technical Writer in the biotechnology /pharmaceutical industry 
Details: 
? Participates in cross-functional teams. 
? Responsible for developing, writing and editing technical documentation while ensuring compliance with applicable regulatory requirements. 
? Normally receives initial and ongoing instruction on routine work and receives general instructions on new assignments. 
? Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. 
? Supports senior colleagues to ensure timelines are met. 
? Works on routine problems or tasks where analysis of situations or data requires evaluation of various factors and guidance from more experienced colleagues. 
? Other QA Focus Areas (Operations, Compliance, Improvement/Training) 
? Manufacturing Operations 
? Commercial Operations 
? QC Operations 
? Validation 
? Material Resource Planning/Distribution 
? CMC/Regulatory Affairs 
? Writes and revises controlled documentation (e.g. procedures, work instructions, forms, specifications, protocols, reports, etc.) 
? Ensures that all documents are technically and mechanically accurate, consistent with internal style guidelines, and consistent with regard to clarity, flow, organization, completeness, accuracy, readability, and/or appropriateness. 
? Communicates with appropriate departments to ensure changes are well documented and easily understood. 
? Interacts with appropriate departments to establish priorities and deadlines for technical documentation. 
? Facilitates the review and approval process and liaises with the business process owner to ensure the document intent is achieved. 
? Verifies own work and ensures the correct and timely implementation of all documentation. Checks format and compliance to company templates. 
? Participates in cross-functional project teams. 
? Performs other related duties and assignments as required. 
? Demonstrates knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks. 
? Demonstrates analytical problem solving skills. 
? Demonstrates ability to explain complex concepts with clarity and simplicity. 
? Demonstrates ability to perform detail-oriented work with a high degree of accuracy. 
? Demonstrates strong verbal, written, and interpersonal communication skills. 
? Demonstrates proficiency in Microsoft Office applications and Adobe Acrobat Professional. 
? 6+ years of relevant experience within the pharmaceutical industry and a BS. 
? 4+ years of relevant experience and a MS Degree. 
? Technical writing experience in the biotech or pharmaceutical industry. 
? Experience with Electronic Document Management Systems or other GXP applications is beneficial.