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QC Biochemist

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
23 Mar 2023
Closing date
19 Apr 2023

View more

Discipline
Quality, QA / QC, QC Analyst
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

On behalf of our client, a diagnostic company, we are currently recruiting for a QC Biochemist. 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 Katie at +353 1 8955770 or email your CV to kgarry@thornshaw.comThornshaw Scientific is a division of the CPL Group www.thornshaw.com

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

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