Skip to main content

QC Biochemist


On behalf of our client, a diagnostic company, we are currently recruiting for a QC Biochemist. This is an 18 month contract role initially. The role will report to the Head of Haemostasis.

Purpose of job:

• To complete routine QC analysis and value assignment to assess suitability of in vitro diagnostic products in the field of Haemostasis and Haematology.

• All duties performed in an ISO and FDA regulated Environment where knowledge and adherence to Standard Operating Procedures within the Quality System is required.

Essential responsibilities:

• Assess suitability of product to the market place by testing product under instructions of the Quality Test Method in the expected time frame allocated as per Master Production Schedule.

• Assign lot specific values to applicable calibrator and control plasmas.

• Carry out microbiological analysis on material and purified water system.

• Generation and completion of Long Term Stability (LTS) protocols for the duration of product shelf life.

• To problem solve and complete root cause analysis as required in addition to Out of Specification (OOS) and Quality Event investigation requirements.

• Monitor batch to batch variation though track and trend (Lot Review) analysis.

• Completion of COA's and lot specific forms for applicable products.

• Highlight any issues/non-compliances and any threat to supply of product

• Calibration of appropriate QC equipment per relevant SOP and/or EOP.

• Ensure the cleanliness and correct labelling of all QC equipment as per Standard Operating Procedures (SOP) and Equipment Operating Procedures (EOP).

• Ensure cleanliness of the lab area and all work surfaces

• Adherence to the quality system and training given at company at all times

• Completion and review of Documentation to cGMP/GDP requirements/standards.

• Flexibility and willingness to carry out overtime as necessary with advance notice

• Maintaining specified reference material quantities.

• Raise change requests in a continuous effort to improve Quality Control records.

• Assess changes through the Change Impact Assessment (TCIA) process.

• Carry out training at individual or group level as required.

Qualifications and Experience:

  • An advanced life science degree
  • Minimum 2 years' experience medical diagnostic/pharmaceutical experience.
  • Quality Control laboratory experience in biological sciences.
  • Demonstrated competence in biochemical techniques, statistical concepts, problem solving and root cause analysis.
  • Understanding of cGMP/GLP requirements and previous regulatory audit experience.
  • Experience and working knowledge of Microsoft Word/Excel and Minitab.
  • A high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative.

Skills and Behaviours:

  • He/She will have excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused.
  • Ability to read, analyse, and interpret technical data, and technical procedures.
  • Excellent problem solving skills will be required.
  • He/She will be an active learner and developer of self and others with excellent organizational skills.
  • Proven to be a team player able to collaborate with and influence multiple other groups in a positive, team-based environment.
  • The successful applicant's professional characteristics will include attention to detail, initiative, ingenuity, creativity, resourcefulness and perseverance.

For full details contact Linda at +353 1 2784701 or email your CV to ldunne@thornshaw.com

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

QC Biochemist

CPL
Dublin
Full time

Published on 17 Sep 2022

Share this job now