Associate Specialist Quality Control

Aphex Group; Carlow; On-site; EUR 55,000 - 75,000; Full time

Job summary

Aphex Group in Ireland is seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab and operations. You will ensure quality pharmaceutical products meet compliance, supply, strategy, and profitability goals, while leading continuous improvement and coaching teams.

You will develop microbiology methods, support environmental monitoring programs, and manage change controls, deviations, and documentation to maintain regulatory compliance and product

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences field is required.
• Minimum 3 years hands-on experience in microbiology/QC, environmental monitoring, utilities monitoring, trending, risk assessments, and data analysis.

Responsibilities

• Support environmental control program through trend analysis and corrective/preventive actions.
• Own environmental monitoring risk assessments and qualification activities.
• Generate quarterly and annual trend reports.
• Apply regulatory/compliance and compendial requirements in daily work.
• Develop and validate microbiology test methods and project validations.
• Troubleshoot issues during validation studies and routine tests.
• Develop training modules for the team.
• Support site investigations related to environmental monitoring and utilities monitoring.
• Drive continuous improvement initiatives, incl. lean lab ideas and method optimization.
• Author and manage change controls, procedures, test methods, and deviations.
• Approve results for microbiological samples to support batch release.
• Assist with GLIMS system updates and documentation.
• Ensure adherence to ALCOA(+) data integrity principles.
• Handle routine tasks with growing technical competence.

Skills

GMP QC

Environmental monitoring

Data analysis

Trend analysis

Regulatory compliance

Change controls

Microbiology methods

Education

Bachelor's degree in Microbiology

Tools

Electronic laboratory systems

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.

• 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