Associate Specialist Quality Control

Aphex Group; Carlow; On-site; EUR 45,000 - 65,000; Full time

Job summary

Aphex Group in Ireland is seeking an Associate Specialist Quality Control to provide scientific oversight in the QC Microbiology Lab and support operations to ensure compliant pharmaceutical production.

The role focuses on environmental monitoring, trend analysis, risk assessment, and method validations, with emphasis on regulatory alignment and continuous improvement. You will author procedures and change controls, and contribute to batch release through microbial testing and data integrity.

Qualifications

• Minimum 3 years hands-on experience in microbiology/QC, 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 understanding of aseptic processing and contamination control in sterile manufacturing.
• Experience in a GMP QC laboratory with knowledge of regulatory expectations.

Responsibilities

• Supporting the environmental control program by trend analysis and implementation of corrective/preventive measures.
• Owner of Environmental monitoring risk assessments and qualification.
• Generation of quarterly and annual trend reports.
• Development and execution of Microbiology test methods and project validations.
• Troubleshooting issues during validation studies and routine tests.
• Authoring and managing change controls, procedures, test methods and deviations.
• Result authorization for microbiological samples to support batch release.

Skills

Troubleshooting

Decision making

Lean lab

Method optimization

Education

Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences

Job description

Purpose

We are seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role is integral to our manufacturing division and requires a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high-performance organization. If you are passionate about driving continuous improvement and delivering technical excellence, we invite you to join our company and make a difference in advancing health solutions. Experience in supporting operations projects with knowledge of regulatory and global compliance requirements. The ideal candidate must have the ability to own and manage projects and deliver on required timelines.

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

Requirements

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