Technical Writer

Morrisville, NC

Posted: 03/15/2019 Job Number: JN -032019-10542
Deviations/Technical Writer (cGMP):

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Deviations/Technical Writer
  • Location: Morrisville, NC
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am 5:00 pm
  • Salary: $30.00-$35.00 hour paid weekly with benefits options
  • Employment Type: Contract To Hire
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products. Isn t this the type of company you want to work for?

Job Scope: This position will support the Production Department and Laboratory Group.
  • Lead the investigation of deviations that occur in operations and are responsible for authoring the investigation
  • Partner with laboratories, quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions
  • Responsible for the closure of deviations
  • Manage several investigations at a time
  • Determine scope, product impact, root cause and corrective actions for deviations from procedures
  • Determine appropriate preventative actions to prevent reoccurrence of the deviation, author deviations and conduct personnel interviews to determine root cause of the deviation
  • Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports
  • Lead and author the investigation of deviations that occur in Operations
  • Assist operations in developing corrective actions
  • Present investigations to relevant groups as needed
Skills Needed:
  • Bachelor s Degree in Chemistry, Biology, Manufacturing Technology or related field
  • 5 years of experience working in deviations in a pharmaceutical manufacturing environment
  • Experience in FDA-regulated industry
  • Excellent presentation skills and Technical Writing/Oral communication skills
  • Proficient in the use of any of the following Root Cause Analysis methodologies: Fish-bone diagram /Ishikawa, Is and Is-Not, Fault Tree Analysis, Human Error Reduction, and 5-WHY
  • TrackWise experience
  • Proficient time management skills, planning and organization capabilities
  • GxP Background. Knowledge of FDA Regulations
  • Operational Excellence skills / Lean-Six Sigma certifications
  • Ability to bring examples of Root Cause Analysis work done to an in-person interview, such as: Fish-bone diagram /Ishikawa, Is and Is-Not, Fault Tree Analysis, Human Error Reduction, and 5-WHY
EOE/ADA

Technical Writer, Technical Writing, Deviations, TrackWise, FDA, cGMP, GMP, Pharmaceutical
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