Technical Writer in Raleigh, NC at Volt

Date Posted: 4/8/2021

Job Snapshot

  • Employee Type:
  • Location:
    Raleigh, NC
  • Job Type:
  • Duration:
    24 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone
    (919) 829-1660

Job Description

Technical Writer

Giant Pharmaceutical company in Raleigh, NC is now hiring a Technical Writer!!

Temp possible Temp to Hire - $30-35/hr - maybe more 

Monday thru Friday 8am - 5pm 

The Technical Writer is responsible for investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. This is a non-supervisory position that reports to the Director, Plant Operations. Interaction with all departments is required in order to understand a problem, identify root cause(s), and implement appropriate corrective and/or preventive actions in order to prevent reoccurrence. Assists Operations and Quality Assurance in determining the disposition of non-conforming in-process product, and determining if a field alert or recall is required for product that has been released. 
This person must be able to: Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process. Works with process experts and production personnel to fully understand and solve problems, 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 review 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, Documentum and other electronic systems to complete tasks. Maintains compliance with company policies, training requirements, cGMPs and safety standards. Assist with revision to SOPs pertaining to component preparation, compounding, filling and stoppering of sterile vials, lyophilizing, capping and inspecting of product. Obtain and maintain aseptic gowning qualification. Assist area supervision with verification and documentation of production activities, including batch records, logbooks, etc to ensure requirements have been met. 
Candidate Qualifications: Associate degree is required; Bachelor of Science degree preferred 2+ years of experience in a GMP manufacturing environment writing standard operating procedures and protocols and/or reports is also required Must be familiar with regulatory (FDA) requirements Good communication and interpersonal skills are necessary.

Volt is an equal opportunity employer.