Quality , Science, Pharmaceutical & Food

QC Analyst HPLC

  • Full Time
  • Remote
  • Limerick
  • 41829990

Responsibilities
Reporting to the QC Chemistry Supervisor, the person will be responsible for the following;

  • Performing a wide variety of analytical chemistry testing to support utilities, raw material, in process and bulk drug substance release.
  • Undertaking HPLC & UPLC analysis on in process and bulk drug substance samples
  • Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
  • Maintains laboratory reagents and supplies.
  • Calibration of laboratory instruments.
  • Participates in the method transfer activities from other test facilities.
  • Provides support and advice to manufacturing on QC related topics.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedure.
  • Writes new and updates current SOPs as needed.
  • Provides training to other analysts in the QC group.
  • Presents analytical data reports clearly and concisely to management.
  • Proactively identifies and implements lab process improvements, lean initiatives.
  • Performs other duties relevant to the QC laboratory position as required.

Requirements

  • A third level qualification in a scientific/technical discipline.
  • At least 2+ year hands-on work experience in a regulated QC laboratory-testing environment within the biopharmaceutical/pharmaceutical industry.
  • Experience in HPLC & UPLC analysis
  • Excellent Communication skills, both verbal & written.
  • Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage.
  • Adaptable and flexible, willing to travel when needed.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.

Preferred Laboratory Experience in one or more of the following areas

  • Analytical
  • HPLC
  • UPLC
  • UV-Vis spectrophotometry
  • Familiar with USP, JP and EP methodology

By continuing to use the site, you agree to the use of cookies. More Information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close