Offers “Sanofi”

Expires soon Sanofi

Quality Control Scientist I

  • Framingham, USA
  • Design / Civil engineering / Industrial engineering

Job description

SHIFT: Monday through Friday 9-5

Quality Control Microbiology supports manufacturing activities at Sanofi’s Framingham Campus by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the difference stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

Quality Control Microbiology Scientist I develops and authors complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics. Solves assay/process problems. Identifies potential problems and proactively suggests technical solutions based upon analytical expertise and knowledge of product/process. Routinely coordinates completion of specific project task with other departments. Contributes to development of project strategy in consultation with manager and/or colleagues.

Core Responsibilities:

· 
Independently plan and execute projects in support of the QC Microbiology Laboratory.

· 
Evaluate new technologies for implementation in the QC Microbiology Laboratory.

· 
Use in-depth technical knowledge to perform method validation.

· 
Perform comprehensive data analysis, prepare statistical analysis of results and write technical reports.

· 
Ensure GMP compliance of all activities performed.

· 
Represent QC Micro in internal and external audits as required.

· 
Oversee, plan and execute QC Micro qualification and re-qualification of lab equipment and campaigns supported by QC Microbiology (cGMP).

· 
Ensure appropriate facility support and provide technical expertise.

· 
Coordinate and support validation, engineering and production assignments according to schedule without compromising quality.

· 
Specify, procure, and coordinate validation and calibration and maintenance of laboratory equipment and instrumentation.

· 
Review standard operating procedures; coordinate method development, alignment and validation as required.

· 
Maintain positive relationship and network effectively across sites and organizations.

· 
Provide in depth training and assist in the writing and development of training qualifications.

· 
Serves as a mentor to less experienced team members.

· 
Perform other additional job related duties as required.

· 
Practice safe work habits and adhere to Sanofi’s safety procedures and guidelines.

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

BASIC QUALIFICATIONS:

· 
Bachelor’s degree in Life Sciences discipline and 5 years of experience in cGMP lab environment, or Master’s degree in Life Sciences discipline and 3 years’ experience in cGMP lab environment, or PhD and 0-2 years' experience in cGMP lab environment.

· 
Proficient in Microsoft Office and lab based data management systems.

· 
Ability to present technical data.

· 
Ability to work independently on scientific projects.

· 
Scientific technical writing ability including authoring and revising SOPs, validation protocols and technical reports.

· 
Experience troubleshooting of assay and equipment issues.

· 
Working knowledge Aseptic practices and technique.

· 
Familiarity with USP and global compendial regulations.

PREFERRED QUALIFICATIONS:

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

· 
Experience in investigations/root cause analysis.

Special Conditions:

· 
Must be able to lift 40 lbs.

· 
Must be able to gown and gain entry to manufacturing areas.

· 
Occasional nights, weekends and holidays may be require.

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.

#GD-SG

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.

Make every future a success.
  • Job directory
  • Business directory