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Technical Writer

Company: Apex Systems
Location: Morrisville
Posted on: June 23, 2022

Job Description:

***Apex Systems has a great Opportunity with a local client for a Technical Investigation Writer. Do you have experience in Writing Investigations? Have you worked in the Pharmaceutical industry before? If so, please take a look at the description below and reach out to us!! Please send resumes to Serena Morris at smorris@apexsystems.com***Job SummaryThe position of Technical Investigation Writer is responsible for leading investigation activities, identifying root cause failure modes, developing failure specific Corrective and Preventative Actions (CAPAs), and writing deviation investigation reports supporting non-conforming (process and procedural) events. To be successful, this individual effectively leverages key investigational tools such as; root cause analysis (RCA), 5-why analysis, and/or fishbone diagrams. Write, edit and review laboratory procedures for accuracy. This role will engage/communicate with all levels of site leadership on the status of all investigations. Job RequirementsEducation and Experience:

  • Bachelor's Degree required, preferably in Sciences (e.g., Chemistry/Biology/Microbiology/Pharmacy)
  • Experience:
  • Minimum 4 years relevant experience in a regulated GMP environment; pharma industry preferred
  • 1-3 years relevant technical writing experience
  • Six Sigma or Lean certification a plus
  • Manufacturing/Laboratory quality assurance experience preferred
  • Strong communication/facilitation experienceKnowledge, Skills and Abilities:
    • Understand Code of Federal Regulation and GMPs.
    • Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity.
    • Ability to establish clear priorities, work efficiently under pressure, handle multiple projects and meet deadlines.
    • Strong verbal and written communication skills; ability to interface with all levels of the organization.
    • Ability to learn and retain technical information.
    • Experienced in most aspects of drug development and lifecycle support.
    • Has substantial breadth/depth of technical acumen in multiple techniques and can understand their application in context of pharmaceutical services offerings.
    • Mathematical and scientific reasoning ability.
    • Capable of rapid learning of unfamiliar principles or techniques with minimum training.
    • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
    • Ability to work effectively under pressure to meet deadlines.
    • Well organized with ability to handle multiple activities simultaneously.
    • Ability to communicate moderately complex technical information to non-technical audiences.
    • High personal credibility with peers and subordinates.
    • Lead by example according to our values and culture.Physical Requirements:
      • Be accessible to laboratory, manufacturing areas and office staff and to use required office equipment. Specific vision requirement includes reading of written documents and use of computer monitor screen frequently.
      • Individual may be required to sit, stand, walk regularly and occasionally lift 0-50 pounds.Working Conditions and Environment:
        • Office area, laboratory and manufacturing areas.

Keywords: Apex Systems, Cary , Technical Writer, Engineering , Morrisville, North Carolina

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