QC Microbiology Team Lead

　　Shift Schedule:

　　2nd Shift, Wednesday to Saturday, 12:00pm to 10:30pm

　　POSITION OVERVIEW

　　DEPARTMENT DESCRIPTION

　　Quality Control (QC) 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 individual is responsible for providing leadership support within the department. The position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.

　　Responsibilities Include:

　　Provide motivation, inspiration, and feedback to staff under general supervision.

　　Manage and coordinate studies and projects

　　Act as the primary contact for the team interacting with various departments

　　Represent the functional area in meetings and compliance activities

　　Actively troubleshoots routine problems with equipment and methods

　　Actively participate in manufacturing scheduling meetings

　　Participate in both internal and external audits

　　Coordinate daily scheduling and assignments

　　Perform and review assays as needed

　　Author/Review technical documents/protocols

　　Assist with interviewing and onboarding new hires

　　Act as Document Owner for SOPs and maintain periodic reviews

　　Run staff daily QDCI/DCM meetings

　　Actively supports the QC Management team

　　Completes Phenix Laboratory investigations/Deviations/CAPA/Change Controls

　　Ensures timely escalation of critical issues

　　Maintains positive relationships and networks effectively across sites and organizations

　　Participates in training more junior employees

　　Ensure all safety requirements are being met within the department including PPE and waste disposal

　　Facilitates operational excellence through continuous improvement initiatives

　　BASIC QUALIFICATIONS:

　　Bachelor's degree or equivalent and 4 years Quality and/or Operations experience in a cGMP laboratory environment

　　PREFERRED QUALIFICATIONS:

　　Bachelor's Degree in a science or technical related field

　　Knowledge Experience with scientific and technical writing

　　Knowledge of CGMP regulations for US, EU and other regulatory agencies

　　Strong computer, verbal, and written communication skills

　　Strong technical writing skills

　　Effective skills in time management, organization, teamwork, collaboration, and leadership

　　Attention to detail

　　• Phenix or other investigation system experience

　　Experience in GMP lab environment.

　　Experience with lab based data management systems.

　　Experience in a quality control lab.

　　SPECIAL WORKING CONDITIONS

　　Work in a laboratory with minimal use of chemicals.

　　Ability to lift 10 lbs.

　　All or part of the information contained in this document should be treated as the property of Sanofi or its affiliates. It cannot be published or divulged for whatever purpose to any third party, unless an appropriate non-disclosure agreement has been signed by the third party and prior approval is obtained from the Sanofi function owning this document.

　　Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.

　　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.

　　Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.

　　Our people are responsible for managing their career

　　Sanofi posts all non-executive opportunities for our people

　　We give priority to internal candidates

　　Managers provide constructive feedback to all internal interviewed candidates

　　We embrace diversity to hire best talent

　　We expect managers to encourage career moves across the whole organization

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