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Quality Engineer

2 months ago

Atlanta, United States Randstad Life Sciences US Full time

A clinical stage biopharmaceutical company on a rapid path to commercialize its proprietary applicator-free, dissolving, microarray patch technology designed to achieve better health outcomes through enhanced therapeutic effects, simplified logistics, and improved patient compliance. Join this team of Scientists and Engineers to make a difference in Health care

Temp to PERM role

Key Skills

  • Change Controls
  • Design of Experiments (DOE)
  • Pharma Quality by Design (QbD)
  • Medical device Design control
  • Risk management


Summary:

Develop, improve, and implement quality engineering program for facility, equipment (analytical and nonanalytical), product, process, computer systems, and methods development/improvement in the FDA regulated biologics, pharmaceutical and medical device industries.


Major Responsibilities

Qualifications

  • Bachelor’s degree or equivalent in an Engineering or other technical discipline.
  • 10+ years’ in Quality related role, with validation experience
  • Experience from design conception through commercial implementation (e.g. URS, DQ, FAT, SAT, IQ, OQ, PQ) desired.
  • Demonstrated ability to apply problem-solving methodology to identify the root cause and implement solutions.
  • Experience in applied statistics – Design of Experiments (DOE), data analyses, sampling plans, process control.
  • Experience data collection and statistical data analysis (e.g. capability analysis)
  • Knowledge and experience with Change Controls, CAPAs, Quality Risk Management, FMEA.
  • Applied Knowledge of Computerized System Validation (CSV) and Data Integrity Principles is desired (e.g. GAMP5 and 21 CFR Part 11).
  • Experience in Facilities related validations is required (e.g. Cleanrooms)
  • Fundamental knowledge of manufacturing processes. Ability to translate quality requirements into product specifications.
  • Self-Starter with excellent technical understanding, writing and communication skills.
  • Able to work with a diverse cross-functional team with minimal supervision.
  • Ability to comprehensively document and communicate validation requirements and deviations encountered.
  • Quality engineering concepts such as statistical analysis, quality testing, sampling and inspection, process control. Minitab and SAP knowledge a plus.
  • Knowledge of ISO, ICH, GMPs, GLP, QSR, Biologics, 21CFR Part 211 and/or 820 regulations.
  • Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated within the company in an efficient, timely, and accurate manner.