Technical Writer - Engineering-II

ID# DCPA28046

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

  • Initiate/write Change Control Request Forms (CCRFs) associated with company's initiated changes to be comunicated to External Manufacturing, Testing, and Packaging sites (hereafter referred to as EM) with input from the EM Contract Account Manager (CAM), Quality Account Manager (QAM) and other Subject Matter Experts (SMEs) as needed. 
  • Initiate/write CCRFs associated with EM site initiated changes with input from the EM CAM, QAM and other SMEs as needed. 
  • Present CCRFs at Change Control Committee (CCC) Meeting with support of CAM and QAM 
  • Interface with the CCRF approvers to align CCRF wording, requirements and deliverabless as needed to facilitate approval process. 
  • Track/monitor CCRFs through their lifecycle. This includes, but is not limited to timely promotion & notification of change in status, regular updates to CCRF owners (CAMs, QAMs & SMEs) on CCRF and deliverable status, weekly monitoring and reporting of change control metrics including submissions, approvals and closures. 
  • Monitor CCRF and deliverable status, initiate extensions when necessary if Target Closure Date is not attainable. 
  • Initiate/write Change Control Implementation Forms (CCIFs) once the CCRF is APPROVED and deliverables are received. 
  • Ensure CCRFs are closed in a timely manner once deliverables are received. 

Education 

  • A minimum of a Bachelor's degree is required. A degree in Sciences or Engineering technologies is preferred. 

Experience 

  • A minimum of 2 years of a cGMP Quality Systems experience in a GMP regulated environment (pharmaceutical, etc.) is required. 
  • 5 years of experience is preferred. Advanced background in Change Control management, administration, improvement, and execution preferred. Proficient in technical writing. 
  • Experience with pharmaceutical manufacturing (processing/packaging), facilities, validation, analytical sciences, microbiology or engineering is required. 

Knowledge/Skillset 

The ability to handle multiple, at times complex change controls at one time is essential. The ability to read, analyze and interpret common scientific and technical documents is required. Organizational skills and the ability to adapt to a fast-paced environment with changing priorities is desired. The ability to effectively present information and communicate clearly to all levels of management is required. The ability to work directly with external manufacturing sites under limited supervision is required. Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, Powerpoint, and Access skills are recommended.) Individual must demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple projects, prioritize and adapt to business needs, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills.

Position Details:

Consumer Product

Engineering

Start Date: 
11-18-2013
End Date: 
5-9-2014

FORT WASHINGTON, PA

CON_W2

40

DCPA28046

No

No