Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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