Associate Technical Writer

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Wilson, United States Randstad Life Sciences US Full time

Immediate need for an Associate Technical Writer with experience supporting GMP Manufacturing for a global, pharmaceutical company located in Wilson, North Carolina. Apply today, and let's start a conversation


Position Type: 1 year, long term contract position. Potential for extension/conversion based on performance and business needs.

Schedule/Shift: 1st shift, Mon.-Fri.


Position Summary: The technical writer is responsible for independently investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned.


Essential Duties and Responsibilities:

  • Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes of facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.
  • Responsible for managing multiple deviation investigations simultaneously.
  • Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.
  • Ensure investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.
  • Works with process experts and production personnel to fully understand and solve problems, provides technical expertise and recommends improvements.
  • Writes Impact Assessments and Investigation Reports, works within TrackWise.
  • Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.
  • Performs continuous reviews and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.
  • Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.
  • Utilizes Word, Excel, Documentation and other electronic systems to complete tasks.
  • Maintains compliance with company policies, training requirements, cGMPs and safety standards.


Qualifications:

  • Bachelor's (BS / BA) degree; experience may be considered in lieu of degree.
  • Three (3) years of experience in a GMP manufacturing environment, writing standard operating procedures, protocols and/or reports.
  • Requires advanced critical thinking skills
  • Must be familiar with regulatory (FDA) requirements
  • Good organizational, communication, and interpersonal skills are necessary
  • Experience with TrackWise and/or Blue Mountain RAM preferred, but not required.

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