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Responsibilities:

  • Responsible for representing the sites quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning for the facility.

Requirements:

  • Bachelor’s Degree required, preferably in Science, Chemistry, or Biology.
  • Minimum of 2-5 years of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical
    device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred. With a
  • Master’s Degree no prior work experience may be necessary.
  • Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk
    Management / HACCP concepts, statistical process control, and statistical problem solving. Also as applicable, strong
    knowledge of Health Canada GMP’s.
  • Professional auditing certification (ASQ, CQA, RAB, or equivalent) preferred for audit responsibilities.
  • FMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science
    certifications (i.e. ASQ, CQE, CMQ/OE) desired.
  • Good verbal and written communication skills to make oral pre.
  • Validation, Change Control, Technical Writing, Process Mapping
  • Experience with Medical Device or Pharma is a big plus.