Orion Group Life Sciences are currently recruiting a Lab Analyst on behalf of our Multinational Biopharmaceutical Client based in Tipperary on an initial 11-Month contract with potential to extend.
Job Purpose
This role provides analytical testing support for all late-stage clinical and marketed drug product manufactured at the Ballydine site. Following MMD approved methods or pharmacopoeia methods, testing will cover raw materials, intermediates and finished product associated with the Drug Product facility. Responsibilities will also include documenting all work in a compliant manner, participating in laboratory investigations, training staff, reviewing analytical results to ensure accuracy and compliance to test methods, preparation of all laboratory documentation and participation in continuous improvement programs.
Job Responsibilities
Adhere to and comply with department high performance behaviours during execution of all work.
Comply with all safety and GMP requirements within the laboratory.
Perform laboratory testing to the pharmacopoeia or MMD approved methods.
Plan daily schedule to meet testing release plans.
Operate laboratory equipment, including daily upkeep, maintenance and assistance with troubleshooting when required.
Prepare and revise laboratory protocols, reports, procedures, etc.
Participate in the training of analytical chemists.
Participate in or lead laboratory investigations, utilizing technical knowledge to identify assignable causes and corrective/preventative actions.
Document all testing activities to current regulatory standards and input data into computerised laboratory systems.
Review analytical results to ensure accuracy and compliance to both test methods and registered specifications.
Participate in and facilitate improvement programs within the laboratory.
Participate in or lead the introduction of new methods and analytical techniques to the Pharm Ops laboratory area.
Participate in multi‑function teams to support project assignments.
Complete additional tasks considered necessary to meet customer requirements.
Work effectively in a multi‑functional team environment.
Core Competencies
Technical
Requires a B.Sc. (or equivalent experience) in analytical chemistry, pharmaceutical science or a related science discipline.
Demonstrated problem‑solving and communication skills.
Strong scientific understanding of analytical methodology and knowledge of relevant regulatory requirements, including cGMP, is important.
Business
Ability to work in partnership with all plant departments related to analytical chemistry and validation.
Identify the business competencies required of the role.
Perform precise and constant analyses in support of various projects.
Communicate technical information verbally and in writing in a concise manner.
Analyze projects, suggest appropriate options, solutions and timelines.
Complete assignments in a timely manner and communicate progress at internal meetings.
Leadership
Demonstrate skills in analytical laboratory techniques.
Teamwork skills.
Leadership of defined projects.
Computer skills: Excel, Word, Outlook, scheduler.
Project management skills.
Interpersonal skills.
Customer service skills.
Written and verbal presentation and communication skills.
Time management.
Educational Requirements
Minimum of BSc in Chemistry or related discipline.
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