Quality Control Microbiology Team Lead

​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.

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.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE

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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