Quality Control Microbiology testing

Sanofi • Pearl River, NY

1d • Onsite

About The Position

This position performs microbiological testing and related analytical functions in the QC microbiology laboratory. Testing follows approved methodologies to help ensure the safety, quality, purity, and stability, as appropriate, of products, components, and in-process stages meet approved specifications. The role also contributes to data trending and periodic reports, raises technical or equipment issues, and works closely with the Microbiology Manager.

The microbiology team provides cross-functional support for manufacturing processes and quality investigations. The role offers opportunities to develop multiple skills and gain experience across the areas of an operational microbiology laboratory. The position is onsite in Pearl River, New York.

Requirements

• Bachelor's degree in Life Sciences, Biology, Chemistry, or a related field.
• At least 1 year of laboratory or manufacturing experience.

Nice To Haves

• Experience in a pharmaceutical or related industrial environment.

Responsibilities

• Perform analytical testing on schedule and in accordance with approved methods, cGMP, HSE requirements, and applicable instructions, procedures, and records.
• Record raw data, calculations, and other task-related information in compliance with cGMP and data integrity requirements.
• Maintain training and qualification to perform assigned analytical testing on a variety of samples, including raw materials, in-process drug substance samples, and environmental monitoring samples.
• Review QC data from tests performed by other analysts when delegated, in a timely manner and according to scheduled plans.
• Promptly inform the manager of quality or HSE events, including deviations and OOx, and participate in investigations and impact assessments.
• Execute assigned CAPAs related to remediation plans and continuous improvement.
• Maintain laboratory facilities and instruments in a suitable quality and safety condition.
• Contribute to environmental and utilities monitoring data trending and assist with or author periodic reports.
• Train team members in analytical testing and documentation when qualified as a trainer, following applicable procedures and cGMP requirements.
• Maintain the laboratory in an audit-ready state and represent the lab team during audits and inspections.
• Revise and update local procedures as needed to align with cGMP/cGLP guidelines and improve usability.
• Build remediation plans related to inspection-readiness gaps, findings, and deviations.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employees may be eligible to participate in company employee benefit programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level