Quality Engineer

Katalyst Healthcares & Life Sciences • Knoxville, TN

240d

About The Position

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.

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.
• 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 presentations.
• Experience with Medical Device or Pharma is a big plus.

Responsibilities

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

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree