Job Title: QC Microbiology Team Lead

Location: Framingham, MA

Shift Schedule:

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

About the job

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.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as [Job Title] within our [Team Name], will be to [summary of opportunity].

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

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.

Main Responsibilities:

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

About You

BASIC QUALIFICATIONS:

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

Associate degree/High School Diploma and 8 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.

Why Choose Us

Bring the miracles of science to life alongside a supportive, future-focused team.​​

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.