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.
• 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 firstname.lastname@example.org
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com