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Technical Writer Consultant

Job Attributes

Job Id:

20871

Job Category:

Clinical & Life Sciences

Job Location:

Summit, NJ  07901

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is currently looking for a Technical Writer in Summit, NJ to work for an international bio-pharmaceutical corporation focusing on the discovery, development, and commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

The Technical Writer Consultant will be supporting Equipment, Commissioning, and Qualification teams that are supporting a new facility build out for commercial manufacturing. 

Responsibilities for the Technical Writer Include:

  • Draft, revise, review, route, and approve SOPs (& periodic reviews), Work Instructions, and other documentation in compliance with GMP regulations
    • Assist with deviations, CAPAs, Change Controls
  • Route documents through proprietary document management system
  • Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
  • Provides technical support and guidance on calibration and maintenance issues.  Interfaces with customers to ensure expectations are being met.
  • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
  • Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
  • Follows up with team members and cross functional team members to encourage timely review and approval.

Qualifications for the Technical Writer Include:

  • Microsoft Office (Word, Excel, PowerPoint Outlook)
  • Understands and works with all components related to web pages, i.e., web parts, lists, pages, libraries, permissions, content and forms
  • Strong working knowledge in computer training systems
  • Working experience with Oracle or SAP 
  • Proven experience with technical writing and document development
  • Strong collaboration abilities across multiple departments
  • FDA/EU/GMP environments and associated compliance regulations

Compensation for the Technical Writer Includes:

  • Compensation commensurate with experience and education
  • Full Benefits: Medical, Dental, Vision, 401(k) plan, Holidays, PTO

Please send qualified resumes to Karen Pallone at kkpallone@pipercompanies.com 

Keywords:

Quality assurance, QA, QC, quality control, gcp, cgcp, gmp, cgmp, FDA, EMA, MCC, regulatory, quality management, pharmaceutical, pharma, combination device, biotechnology, regulatory, benefits, vacation, holiday, 401(k)

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Job Id:

20871

Job Category:

Clinical & Life Sciences

Job Location:

Summit, NJ  07901

Security Clearance:

No Clearance

Business Unit:

Piper Companies