Quality Analyst Microbiology

Sanofi Inc.; Gloucester; On-site; GBP 36,000 - 48,000; Full time

Job summary

Sanofi in Waterford, Ireland, seeks a Quality Analyst Microbiology to support QC and ensure products meet safety, quality and stability specs. The role includes performing QC testing, batch release review, and collaborating across Validation, Manufacturing and QA teams.

The successful candidate will have microbiology QC experience in GMP settings, knowledge of quality systems such as Trackwise and LUNA, and a bachelor’s degree in a scientific field.

Qualifications

• Experience in a QC department in a Pharmaceutical or GMP facility.
• Experience in Microbiological techniques.
• Knowledge of quality management systems such as Veeva/Qualipso/Trackwise.
• Knowledge of lab management systems such as LUNA.
• Bachelor’s degree in a scientific discipline.

Responsibilities

• Provide Microbiology support to QA, QP, Validation and Manufacturing, and other on-site areas.
• Documentation review and batch release review.
• Provide technical guidance to the QC Microbiology Team and external departments.
• Execute QC Microbiology testing (water sampling, water testing, environmental monitoring, compressed air/nitrogen) as required.
• Ensure compliance with cGMP and SOPs and pharmacopeias at all times.
• Contribute to continuous improvement initiatives in the lab.
• Represent QC Microbiology at cross-functional meetings.

Skills

QC Microbiology

Communication

Cross-functional teamwork

GMP

Education

Bachelor's degree in a Scientific discipline

Tools

Veeva/Qualipso/Trackwise

LUNA

Job description

Job title: Quality Analyst MicrobiologyLocation: Waterford, IrelandContract type: Fixed term 12 months

About the Job

As Quality Analyst Microbiology within our QC Team, you'll provide chemistry support and knowledge to the QC team and to other departments. Ready to get started? This position also includes performing QC testing by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications. The chemistry team is highly flexible and provides cross functional support. This role allows opportunity to become highly skilled within the team and gain experience in all areas essential to the running of a microbiology department.

About Sanofi:

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that
treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities:

• Provide Microbiology support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
• Documentation review and batch release review.
• Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with Validation, Manufacturing, Planning and Quality Assurance.
• Execution of QC Microbiology testing (water sampling, water testing, environmental monitoring, compressed air/nitrogen and more) as required.
• Compliance with cGMP and Standard Operating Procedures and pharmacopeias at all times.
• Actively contribute to continuous improvement initiatives in the lab.
• QC Microbiology representation at cross functional meetings.

About Waterford

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients
around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing. This will be a 12/7 shift role (4 x12 hr days). Changes to hours may be a requirement in future including shift hours (nights and weekends). Overtime may be required.

About you

Experience: experience within a QC department in a Pharmaceutical or GMP facility; Experience in Microbiological techniques; understands Key Performance Indicators. Soft and technical skills: Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo; Knowledge of quality
management systems (e.g. Veeva/Qualipso/Trackwise); Knowledge of lab management systems (e.g. LUNA); Be a motivated, ambitious and goal oriented individual. Education: Bachelors Degree in a Scientific discipline (Biology, Chemistry, Biotechnology, Biochemistry or Food science preferred).

Why choose us?

Be part of a pioneering biopharma company where patient insights shape drug development. Work at the forefront of AI-powered science that accelerates discovery and improves outcomes. Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams. Explore bold career paths - with opportunities to grow through scientific, leadership, and cross-functional moves. Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks' gender-neutral parental leave.

#LI-EUR#LI-Onsite

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just
as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve.

Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary - together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.