Senior QC Analyst - 24 Month Secondment/FTC

Pharmadog; Ireland; Remote; EUR 70,000 - 95,000; Full time

Job summary

AstraZeneca and Alexion in Athlone, Ireland, is seeking a Senior QC Analyst (Microbiology) for a 24-month secondment/FTC on a night shift. You will lead microbiology testing, sterility assurance, method validation, and laboratory compliance to support both clinical and commercial manufacturing.

You'll provide technical leadership across QA activities, contribute to continuous improvement, partner with cross-functional teams, review documentation, and support regulatory inspections while

Qualifications

• Degree or equivalent in Microbiology or related discipline.
• Significant experience in a cGMP-regulated pharmaceutical/biotech environment.
• Experience supporting sterile drug product manufacturing and aseptic processing.
• Strong understanding of microbiology and sterility requirements in regulated manufacturing.
• Expertise in microbiological method validation, endotoxin testing, and sterility testing.
• Experience conducting quality investigations and applying risk management principles.
• Knowledge of LIMS and experience supporting system implementation or optimisation.
• Strong technical writing, documentation, and data review skills.

Responsibilities

• Provide technical leadership across microbiology testing and environmental monitoring.
• Support microbiology laboratory operations while ensuring cGMP compliance.
• Lead method validation and qualification activities for microbiological tests.
• Develop, implement, and optimise Laboratory Information Management Systems (LIMS).
• Lead and participate in Quality Risk Assessments and continuous improvement initiatives.
• Investigate out-of-specification and out-of-trend results and implement CAPAs.
• Review, interpret, and author technical documentation including validation reports and SOPs.
• Perform technical review and approval of microbiological data.
• Support regulatory inspections and customer audits.
• Provide training and guidance to laboratory personnel.
• Contribute to project activities supporting manufacturing operations and new technologies.
• Act as escalation point for complex laboratory issues and deputise for Lab Supervisor.

Skills

Microbiology expertise

cGMP experience

Quality investigations

LIMS knowledge

Technical leadership

Education

Degree in Microbiology

Tools

LIMS

Aseptic processing

Sterility testing

Job description

Senior QC Analyst (Microbiology) – 24 Month Secondment/FTC
Night Shift –
Week 1: 7pm – 7am (Mon, Tues, Sat, Sun)
Week 2: 7pm – 7am (Wed, Thurs, Fri)
Location: Athlone, Ireland

Help shape the future of quality and patient safety
Are you an experienced microbiology professional looking to make a significant impact in a highly regulated pharmaceutical environment? We are seeking a Senior QC Analyst to join our Quality Control team in Athlone.
As part of this position, you will provide technical expertise and leadership across microbiology testing, sterility assurance, method validation, and laboratory compliance activities. You will play a key role in supporting product quality, regulatory compliance, continuous improvement initiatives, and the implementation of new technologies within the laboratory.
Working closely with Quality, Manufacturing, Technical Operations, and other cross-functional teams, you'll help ensure the highest standards of quality while contributing to innovative projects that support both clinical and commercial manufacturing.

What you'll do

• Provide technical leadership and subject matter expertise across microbiology testing and environmental monitoring activities.
• Support microbiology laboratory operations while ensuring compliance with cGMP, GLP, regulatory, and company requirements.
• Lead and support method validation and qualification activities for microbiological test methods and systems.
• Partner with colleagues to develop, implement, and optimise Laboratory Information Management Systems (LIMS).
• Lead and participate in Quality Risk Assessments and continuous improvement initiatives.
• Investigate out-of-specification and out-of-trend results, identify root causes, and implement effective corrective and preventive actions.
• Review, interpret, and author technical documentation, including validation protocols, reports, investigations, and standard operating procedures.
• Perform technical review and approval of microbiological data.
• Support internal and external regulatory inspections and customer audits.
• Provide technical guidance and training to laboratory personnel.
• Contribute to project activities supporting manufacturing operations, new technologies, and laboratory improvements.
• Act as a key escalation point for troubleshooting complex laboratory issues.
• Support laboratory scheduling and operations, including deputising for the Laboratory Supervisor when required.

What you'll bring

Essential qualifications and experience

• Degree or equivalent experience in Microbiology or a related scientific discipline.
• Significant experience within a cGMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience supporting sterile drug product manufacturing and aseptic processing.
• Strong understanding of microbiology and sterility assurance requirements within regulated manufacturing operations.
• Expertise in microbiological method validation, endotoxin testing, and sterility testing.
• Experience conducting quality investigations and applying risk management principles.
• Knowledge of LIMS and experience supporting system implementation or optimisation.
• Strong technical writing, documentation, and data review skills.

Desired skills and experience

• Sophisticated technical knowledge of sterility assurance, aseptic processing, and microbiological testing methodologies.
• Experience supporting both clinical and commercial manufacturing environments.
• Ability to build strong collaborative relationships across multiple functions and sites.
• Excellent problem-solving and root cause analysis capabilities.
• A continuous improvement attitude with experience driving efficiency and compliance enhancements.
• Strong planning, organisation, and prioritisation skills.
• Ability to coach, mentor, and develop colleagues.
• Excellent written and verbal communication skills.
• Strong digital literacy, including experience with digital platforms and a working knowledge of AI tools and technologies.

Why join us?

You'll be part of a collaborative and supportive team where your expertise will directly contribute to product quality, patient safety, and operational perfection. We value diverse perspectives and encourage innovation, continuous learning, and professional growth.
If you're passionate about microbiology, quality, and driving improvements in a fast‑paced pharmaceutical environment, we'd love to hear from you.

Inclusive hiring statement

We are committed to creating an inclusive workplace where everyone can thrive. We welcome applications from candidates of all backgrounds, experiences, and perspectives. If you don't meet every requirement listed but believe your skills and experience would enable you to succeed in this role, we encourage you to apply.

Date Posted

28-Aug-2026
11-Sept-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.