New · posted Nov 8
Sanofi · Pharmaceuticals
Quality Control Microbiology testing
- Pearl River, NY
- On-site
- Full-time
- Associate & Specialist
The role
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.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
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.
Key Roles (D,A,I)
- Build remediation plans related to inspection readiness gaps, findings, deviations, … (A)
What you need
Basic Qualifications
- Bachelor's degree in Life sciences, Biology, Chemistry or related field.
- 1+ Years of laboratory or manufacturing experience.
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
Preferred qualificationsnice to have
- Experience in a pharmaceutical or related industrial environment.
What you'll do
- 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
Pay and benefits
$69,000 – $99,667 a year
Employer providedNorth 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.
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.
14weeks
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.
Where you'll work
Pearl River, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Pearl River, NY
From the posting
About Sanofi
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.
Equal opportunity, accessibility and legal noticesSanofi's statements, word for word
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action 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.
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Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% above the US median for Microbiology & Sterility Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $69,000 | — | $99,667 |
| All US (middle half) | $66,000 | $72,500 | $81,000 |
This role: Sanofi's own published range. Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 57 open Microbiology & Sterility Assurance roles on Regulatory Jobs, with the titles they carry most. Not Sanofi's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods9
- GMP and compliance7
- Documentation and SOPs6
- Investigations and CAPA4
- Collaboration and leadership3
- Data and digital systems2
- Validation and qualification1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility Assurance work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
Company hiring pulse
Sanofi on Regulatory Jobs
- 26
- Open roles
- 26
- Distinct roles
- 7
- Locations
By discipline
- Quality17 65%
- Clinical5 19%
- Regulatory4 15%
By level
- Senior & Principal9 35%
- Associate & Specialist7 27%
- Director5 19%
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Quality Control Microbiology testing at Sanofi
Applications close November 30. $69K–$100K a year, employer provided.