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KCAS is looking for a Quality Assurance Specialist II

KCAS Bioanalytical & Biomarker Services is seeking a Quality Assurance Specialist II in our Quality Assurance department. He/she will perform activities of some variety and complexity to assure KCAS management of quality and compliance with applicable regulatory requirements as well as perform document control/ processing functions.

Critical Functions 

  • Performs quality review and approval of documents, data, protocols, and/or reports.
  • Performs quality audits and/or inspections.
  • Prepares and distributes audit reports.
  • Reports findings to study director, principal investigator and management in a timely manner.
  • Reviews laboratory deviations and investigations.
  • Maintains quality databases and may perform analysis and trending.
  • Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed.  
  • Effectively performs a variety of duties, on schedule, with accuracy and competency.
  • Maintains accurate quality assurance files and records.
  • This position will primarily be working on Large Molecule.

Requirements

Education Requirements

  • Bachelor of Science or Arts in Chemistry/ Biology or related field is preferred.

Knowledge and Job Requirements

  • Quality analysis or auditing experience in Large Molecule.
  • Good oral and written communication and math skills.
  • Strong computer skills, including Microsoft Office.
  • Demonstrated ability to exercise independent judgment with little supervision and work as part of a multi-disciplinary team in a fast paced environment.
  • This is a position in Quality, however, Large Molecule lab experience a plus.
  • Watson or LIMS experience is desired.

To submit your resume, contact us at Resume.Mailbox@KCASbio.com.