QC Micro Analyst

AMARIS GROUP SA; Latina; In loco; EUR 26.000 - 50.000; Tempo pieno

Vantaggi offerti da questo lavoro

International team

Comprehensive training

Team events

Descrizione del lavoro

Amaris Consulting is seeking a microbiological quality control professional in Italy to review and validate bioburden, LAL, endotoxin, and sterility tests, ensuring GMP/ISO compliance. The role involves drafting technical comments and coordinating with production and QA teams, with responsibilities including SOP maintenance and validation document reviews.

The candidate should have 6–12 months of relevant experience, strong analytical skills, precision, and good teamwork and communication.

Competenze

• Experience with microbiological tests including Bioburden, LAL, endotoxin detection, and sterility testing.
• Knowledge of GMP and ISO regulations applicable to the pharmaceutical industry.
• 6–12 months of experience in similar microbiological quality control roles.

Mansioni

• Review documentation related to microbiological tests to verify quality standards.
• Evaluate and approve sterility and endotoxin test reports for accuracy and procedures.
• Draft technical comments on laboratory results and request data corrections when needed.
• Monitor microbiological quality control procedures in compliance with GMP/ISO.
• Coordinate with production and QA teams for technical clarifications and documentation alignment.
• Review and approve microbiological validation documentation for instruments and processes.
• Maintain and update technical docs and SOPs for consistency and compliance.
• Work on a continuous shift including nights.

Conoscenze

Bioburden

LAL test

Endotoxin testing

Sterility testing

GMP & ISO

Analytical thinking

Problem solving

Teamwork

Communication

Italian language

English language

Biology degree

Descrizione del lavoro

Join our team and start a new adventure in an international and dynamic environment, where you will be able to shape your professional ambitions in a fast-growing organization. As an Amaris consultant, you will position yourself as a technical and functional expert in your field, representing our company with clients, building trustful relationships, and tackling their challenges with competence and passion.

Your Missions

• Review documentation related to microbiological tests, including bioburden and LAL tests, to verify compliance with required quality standards.
• Evaluate and approve reports of sterility tests and endotoxin tests, ensuring accuracy, completeness, and adherence to procedures.
• Critically analyze laboratory results provided by analysts and draft technical comments or requests for integration/correction.
• Control and monitor microbiological quality control procedures, ensuring they are performed according to current regulations (GMP, ISO).
• Interface with production and quality teams for technical clarifications and to ensure documentation accurately reflects compliance with sterility protocols.
• Review and approve microbiological validation documentation related to instruments and processes.
• Verify, update, and maintain technical documentation and standard operating procedures (SOP), ensuring consistency and compliance.
• Work on a continuous shift including nights.

Your Profile

• Experience with microbiological tests: Bioburden, LAL test, endotoxin detection, sterility testing.
• Knowledge of GMP and ISO regulations applicable to the pharmaceutical industry.
• 6 months/ 1 year of experience in similar roles in microbiological quality control.
• Analytical and problem-solving skills in regulated environments.
• Precision and attention to detail in laboratory activities and documentation.
• Excellent teamwork and communication skills with various stakeholders.
• Academic background: Degree in Biology or related disciplines (mandatory).
• Italian fluent. English good.

What We Offer

• An international community bringing together 110+ different nationalities.
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibility.
• A robust training system with our internal Academy and 250+ available modules.
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.).
• At Amaris, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.
• Gross Annual Salary (GAS): EUR 26,000- EUR 50,000 ; basic salary only, the variable component will be detailed in the offer

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technologyconsulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of7,600 people spread across 5 continents and more than 60countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.