Quality Control Microbiology testing

Regulatory Toolkit; Pearl River (NY); On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi in Pearl River, NY is hiring for a Quality Control Microbiology testing role. You will perform microbiological testing and related analytical tasks to ensure safety, quality and stability of products, with emphasis on data trending and reporting.

The role supports cross-functional manufacturing processes and quality investigations, offering opportunities to multi-skill across the QC microbiology lab under the guidance of the Microbiology Manager.

Qualifications

• Bachelor's degree in Life sciences or related field.
• 1+ years of laboratory or manufacturing experience.
• Experience in a pharmaceutical or related industrial environment preferred.

Responsibilities

• Execute analytical microbiology testing in a timely manner per committed plans.
• Record all raw data, calculations and information to ensure data integrity per cGMP.
• Ensure training and qualification to perform analytical testing on samples (raw materials, in-process drug substance, environmental monitoring).
• Perform QC data review of tests performed by others in a timely manner.
• Inform manager of quality or HSE events to trigger investigation and impact assessment.
• Participate in investigations and contribute to remediation and continuous improvement plans.
• Ensure lab instruments and facilities are maintained in a compliant quality and safety status.

Skills

Microbiology testing

cGMP compliance

Data trending

Environmental monitoring

Education

Bachelor's degree in Life sciences

Job description

Job Title: Quality Control Microbiology testing

Location: Pearl River, NY

About The Job:

The function of this position is to perform microbiological testing and related analytical functions in the QC microbiology lab. This position includes performing microbiological and other testing following approved methodology to assure that the safety, quality, purity and stability (as appropriate) of our systems products, components and in- process stages are in compliance with approved specifications. Additionally, this position provides input for data trending and assists with or authors periodic reports as necessary, highlights problems related to technical and equipment issues, and works closely with the Microbiology Manager. The microbiology team is highly flexible and provides cross functional support as part of manufacturing processes and quality investigations. This role allows opportunity to become multi skilled with the team and gain experience/skills within all areas essential to working within an operational microbiology laboratory.

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:

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to perform the assigned analytical testing on a variety of samples (e.g. raw materials, in-process drug substance samples, environmental monitoring, etc.)
• Performing the QC data review of executed tests by other analysts in a timely manner based on managerial delegation, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively in any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

Key Roles (D,A,I)

• Build remediation plans related to inspection readiness gaps, findings, deviations, … (A)

Additional Accountabilities

• Contributing to trending of environmental monitoring and utilities monitoring data and assisting with/authoring periodic reports as necessary
• Training team members in analytical testing and documentation upon trainer qualification, ensuring adherence to local and global standard operating procedures and cGMP requirements
• Ensuring the laboratory is maintained in an audit-ready state at all times and represent the lab team during audits/inspections
• Revising and updating local procedures as necessary to align with cGMP/cGLP guidelines and enhance ease of use for laboratory activities

About You:

Basic Qualifications:

• Bachelor's degree in Life sciences, Biology, Chemistry or related field.
• 1+ Years of laboratory or manufacturing experience.

Preferred qualifications:

• Experience in a pharmaceutical or related industrial environment.

Why Choose Us:

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Shape the future of medicine and vaccine delivery with cutting‑edge technology, ensuring seamless launches and a resilient global supply.
• Power industry‑leading performance by leveraging digital, data, and AI‑driven innovation – at speed and scale.
• Transform lives worldwide by delivering life‑changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiant employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$69.000,00 - $99.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.