Laboratory Data Reviewer

  • Location
    Newry, Antrim
  • Salary
    £ 28000 - £ 32000 / Year
  • Job type
    Permanent
  • Industry
    Science and Research
  • External Reference
    JN-062022-259034
  • Category
    Science - Biomedical Engineering

Job Overview


Based within the R&D GLP Clinical Section the Laboratory Data Reviewer will be responsible for reviewing laboratory data to ensure accuracy and validity of analysis conducted within the department. This role involves the review of data generated within the Chromatography Data Capture System (Empower ™) and associated analytical records and generation of analytical and validation reports to ensure delivery of Studies and validations to project timelines.



Main Activities/Tasks


- Review of GLP Laboratory study & validation analytical data (electronic and paper data) for accuracy and validity in line with GLP (SI 3106), VICH guidance and in-house procedures.


- Communication with the laboratory analytical team to ensure data queries are addressed prior to data set approval.


- To prepare/review Study Analytical Reports and Method Validation Reports as per VICH guidance and in line with project timelines,


- Review and assist with the implementation of Standard Operating Methods (SOMs) and Standard Operating Procedures (SOPs) as applicable for the GLP Laboratories.


- Assist in the preparation and review of Validation Protocols in line with regulatory requirements. - A key playerin a cross-functional team working closely with analysts, laboratory management, GLP Study Directors and QA to ensure analytical data and reports are reviewed and delivered in compliance with GLP and VICH requirements.



Essential Criteria



- A degree in a relevant Science based discipline or a minimum of 2 years practical HPLC analytical experience.


- Knowledge of Electronic Chromatography Data Capture system (Empower or similar chromatography software package).


- Good team player organised and accurate with strong documentation skills.


- Ability to develop effective working relationships in cross-functional teams and work closely with a range of departments.


- Proven troubleshooting and problem-solving skills.


- Self-directed, can work independently, and proactive as a team member, being highly motivated and result orientated.


- Good written and oral communication skills, able to interact positively and professionally with a range of departments


- Good team player organised and accurate with strong documentation skills.



Desirable Criteria


- Experience of preparing laboratory method, Standard Operating Procedures (SOPs) and laboratory analytical reports


- Experience working with an electronic chromatography data capture system


- Experience reviewing data within an electronic chromatography data capture system


- Knowledge of bioanalysis


- Previous Data records review experience within a GMP/GLP laboratory environment


- Knowledge of method validation according to GMP/GLP guidelines would be an advantage




Duration



Full time, Permanent Location:


Newry, Co. Down Remuneration:


Salary Attractive Benefits: Free Life Assurance, Company Pension Scheme, 30 days annual leave, Wedding Leave, Employee well-being initiatives, Healthcare plan, Company Sick Pay, Employee Assistance Programme, on-site free parking, Canteen Facilities, Employee Perks scheme, Discounted Car Insurance, Annual Employee raffle, employee recognition scheme, career development opportunities and much more

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.


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To speak to a recruitment expert please contact Neil McCallum