Associate QC Microbiology Specialist

Orion Group Life Sciences are currently recruiting an Associate QC Microbiology Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.
 
Monday - Friday role, 8:00- 16:30 and will be fully onsite
 
 
Key Responsibilities

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
• Supporting and owner of Environmental monitoring risk assessments and qualification.
• Generation of quarterly and annual trend reports.
• Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Development and execution of Microbiology test methods and project validations.
• Troubleshooting of issues which arise during the execution of validation studies and routine tests.
• Development of training modules.
• Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring.
• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
• Authoring and managing change controls, procedures, test methods and deviations.
• Result authorization for microbiological samples to support batch release.
• GLIMS System updates.
• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
• Supporting lab stock management and financial control as required.
• Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests.
• Making decisions within guidelines and policies which impact microbiology projects.
• Ensuring highest safety standards.
• Performing other duties as assigned.

 
 
Qualifications
 
Required

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field.
• Minimum 3 years of hands-on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.
• Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements.
• Strong troubleshooting, decision-making, and ability to drive improvements such as lean lab initiatives and method optimization.
• Strong microbiology background and strong understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing.
• Experience in a GMP QC laboratory with knowledge of regulatory expectations.
• Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation.
• Entry- to early-career level with growing technical competence; able to perform routine tasks with limited discretion.

 
Preferred

• Experience with problem solving, decision making, scheduling of laboratory testing/tasks

 
 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.