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Quality Control Principal Team Lead

Framingham, Massachusetts

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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

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Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

Shift Hours: Sunday through Wednesday 7:00 AM to 5:30 PM

DEPARTMENT DESCRIPTION:

Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site wide studies and projects.

POSITION SUMMARY:

This position is responsible for overseeing the shift operations, including performing routine and complex testing of in-process sampl­­es and final products in accordance with SOPs and relevant procedures for method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.

Responsibilities include:

  • Provide leadership of the shift, including but not limited to: mentoring/coaching, training, scheduling, coordination with other departments, management of timelines, and troubleshooting of issues.

  • Perform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations. 

  • Perform maintenance on complex laboratory equipment.

  • Review data for compliance to procedures and specifications.

  • Calculate and evaluate results.

  • Make detailed observations in support of Alert, Action and OOS result investigations.

  • Participate in training of less experienced staff.

  • Develop and author complex and explicit documentation for new and current

  • procedures and technical reports.

  • Implement new technologies/instrumentation in the QC laboratory.

  • May act as Manager delegate.

  • Effectively demonstrate an understanding of and work in compliance with CGMPs.

  • Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines.

  • Monitor method data trending.

  • May participate in communications inter-departmentally and with outside contacts to solve technical issues.

  • May assist supervisor in determining technical objectives and approaches to assignment.

  • Identify deviations from QC methods and develop appropriate CAPAs.

  • Recommend method improvements.

  • Represent QC as the prime technical contact for laboratory projects.

  • May work independently with little supervision. 

  • May assist in non-technical projects which affect the department as a whole. (e.g. safety programs).

* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

LEADERSHIP QUALIFICATIONS INCLUDE:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.

  • Being honest and treating people with respect and courtesy.

  • Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.

  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

BASIC QUALIFICATIONS:

  • Bachelor’s degree or equivalent and 6+ years of laboratory experience.

  • Master’s degree or equivalent and 4+ years of laboratory experience.

  • Proficient with Microsoft Office tools such as: Word, Excel & Powerpoint.

  • Ability to work independently on scientific projects.

  • Familiarity with USP and global compendia! regulations.

  • Scientific technical writing ability including authoring and revising SOPs or technical reports.

  • Experience troubleshooting of assay and equipment issues.

PREFERRED QUALIFICATIONS:

  • Experience with lab-based data management, digital solutions, and quality systems.

  • Experience in investigations/root cause analysis

SPECIAL CONDITIONS:

  • Work in a laboratory with minimal use of chemicals.

  • Ability to lift 10 lbs.

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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