Technical Writer in Branchburg, NJ

  • Title: Technical Writer
  • Code: RCI-20118
  • Location: Branchburg, NJ 08876
  • Posted Date: 11/23/2022
  • Duration: 12 Months
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  Job Description

2 days a week remote once onboarded

Length of Contract: 1 year (although I may want to start with a 3 month increment to confirm good fit)

JOB SUMMARY:

The Senior Technical Writer is responsible for the development, creation, and revision of controlled documentation in accordance with client policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Establishes partnerships with Managers and supervisors in Production. Works with Change Control, Quality Investigations /CAPA team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information/parameters per process/product specifications.

KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:                             

  • Work under minimal supervision to author changes to production based controlled documentation, including but not limited to operating procedures, work instructions, batch records and forms.
  • Act as Initiator for Change Controls. Works with complex tasks and tight deadlines. Responsible for the execution of all steps to ensure timely completion of changes.
  • Participate in project team meetings, working collaboratively with project team members from Manufacturing, Engineering, Process Development, Quality and other subject-matter experts to develop document content.
  • Gathers information from SMEs, breaks complex processes into straightforward steps and ensures that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity.
  • Ensure that technical information and parameters contained within operating procedures, work instructions and related forms match those parameters identified in associated validations and/or verifications.
  • Assist SMEs in creating first drafts from process maps, outlines, and direct observation.
  • Create new or revise existing content with a high degree of quality.
  • Act as subject matter expert in document creation, format and alteration.
  • Ensure that the information contained in procedures corresponds with the information on related documentation such as forms, inspection records, etc. including the appropriate verifications steps.
  • Identifies areas for improvement within existing documentation and provides creative ways to make all documents better.
  • Maintains records on changes and provides reports to supervisor.
  • Gathers information, analyzes and determines best approach for complex production process changes.
  • Influences and negotiates with coworkers at various.levels to resolve NCRs and CAPAs.
  • Maintains records on changes and provides reports to supervisor.
  • Gathers information, analyzes and determines best approach for complex production process changes.
  • Influences and negotiates with coworkers at various.levels to resolve NCRs and CAPAs

JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):

  • The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Education and Experience

  • University Degree    
  • BA/BS, Bioscience, Business, English or Education (preferred)Previous experience in pharmaceutical, medical device, or biotech industries3-5 years experience in Technical Writing in a GMP or medical device manufacturing environment.
  • In depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.
  • In depth knowledge of ERP System (SAP)
  • Project Management capabilities

Are you open to look at candidates willing to relocate?

  • No, temp position

Years of experience/education and/or certifications required:

  • University Degree – BA/BS – Bioscience, Business, English or Education (preferred)
  • Previous experience in medical device, biotech industries or pharmaceutical
  • 3-5 years’ experience in Technical Writing, in a GMP or medical device manufacturing environment

What are the top 3-5 skills requirements should this person have?

  • In depth knowledge of MS Word, including use of tables, headers/footers, and review capabilities (FS-Pro knowledge a plus)
  • In depth knowledge of Electronic Document Management Systems (Veeva a plus, others are acceptable)
  • Project Management Capabilities
  • Superior communication Skills
  • Drive Execution
  • Build Relationships

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

  • Knowledge of TrackWise, SAP, Maximo systems.

Work Schedule (Define days,# of hours)/ Is Overtime offered or required?

  • M-F, 40 hours a week, OT not required

Does this position offer the ability to work remotely on a regular basis?

  • 2 days a week remote once onboarded

Is the worker onshore or offshore?

  • Onshore


About Rangam:

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
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