Quality Control Microbiology testing

BioSpace; Pearl River (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

Sanofi Inc. Pearl River, NY is seeking a Quality Control Microbiology tester to perform microbiological testing and related analytics in the QC lab.

This role supports product safety and quality by following approved methods and cGMP requirements, while assisting with data trending and periodic reports under the supervision of the Microbiology Manager. You will gain experience across essential analytical activities in a manufacturing environment, contributing to investigations and CAPA efforts

Qualifications

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

Responsibilities

• Execute analytical testing in a timely manner per schedule.
• Perform tasks per cGMP/HSE requirements and associated procedures.
• Record raw data and calculations to meet cGMP and data integrity.
• Ensure training and qualification to perform analytical testing on diverse samples.
• QC data review of executed tests in a timely manner per management delegation.
• Inform manager of quality or HSE events to enable investigations.
• Participate in investigations to assess impact.
• Execute CAPAs related to remediation and continuous improvements.
• Maintain lab facilities and instruments in quality and safety status.
• Build remediation plans for inspection readiness gaps and deviations.

Education

Bachelor's degree in Life sciences, Biology, Chemistry or related field

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. 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 peoples 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 peoples 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
• 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 its 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.

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.

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Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff…