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Sanofi Group Quality Control Scientist II in Ridgefield, New Jersey

SUMMARY:

The Micro QC Scientist II is dedicated to the Microbiology Laboratory and EM Monitoring Program. The role of the Micro QC Scientist II will be that of a Subject Matter Expert for any lab or EM as related to Microbiology, Testing, Aseptic Practices, Environmental Monitoring for Controlled Facilitates. The candidate will review, author, and execute Micro validation studies. The Candidate will mentor and educate the junior Analysts on matters directly related to lab operation and testing.

JOB RESPONSIBILITIES:

The Micro QC Scientist II is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing direction, mentoring, and completing high-level projects for the Micro team. This position also includes product testing, release EM Monitoring, data review, and validation.

  • HOURS: Monday - Friday from 8:00 am to 4:30 pm. Some flex in the start and end times may be allowed; weekend work and overtime as required.

  • Exceptional knowledge of USP, EU, and ISO regulations is a must.

  • The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays

  • Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.

  • Validation protocol writing, review, and execution (or overseeing validation execution)

  • SOP review, creation, and approval

  • OOS investigations writing/review and approval.

  • Mentor junior Analysts on testing, troubleshooting and Lab related items

  • Ensure compliance with all cGMP standards, safety, and environmental regulations and company SOPs.

  • Provide advice to subordinates based on general policies and management guidance.

  • Ensure that high-level projects are completed on schedule and accurately.

  • Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.

  • Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.

  • Support regulatory, third party, and internal audits when required.

  • Conveys complex information in a concise manner

  • Motivate and Develop teams.

  • Interact with Project Teams and cross-functional groups related to site operations

ANALYST QUALIFICATIONS:

The Micro QC Scientist II is expected to act on and demonstrate the Sanofi LEAD competencies:

  • Act for Change: Embrace change and innovation and initiate new and improved ways.

  • Cooperate transversally: Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.

  • Develop People: Take responsibility for developing one’s self and mentor other Micro Personnel in anticipation of future business needs or to assist the micro department.

JOB REQUIREMENTS:

  • Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and stand for at least 4 hours.

Education & Experience

  • BA/BS in Microbiology/Biology with 6-10 years experience is required.

  • A thorough understanding of validation testing; write, execute and report validation studies

  • Practical experience in general microbiology laboratory techniques working with bacteria, yeast, and mold.

  • Prior experience with, writing protocols, data review, authoring SOPS, Change Controls, out-of-specification investigations, and report writing.

  • Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing

  • Excellent technical writing skills

  • Ability to collaborate effectively with personnel and between departments

  • Strong analytical and problem-solving skills

  • Make sound judgment from data

  • Strong communicator

  • Works independently

  • Working knowledge of Word, Excel, and PowerPoint

  • Preferred experience with a deviation/CAPA enterprise system

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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