Location
Framingham, MA | United States
Job description
Shift Schedule: Sunday-Wednesday, 10 AM – 8:30 PM
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. Quality Control is also responsible for assisting in site wide studies and projects.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Position Summary:
This position is responsible for 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.
Core Responsibilities:
Perform laboratory assays in support of Method Development, Product Release, and Stability.
Troubleshoot assay and Instrument problems with departmental leads.
Review data for compliance to procedures and specifications.
Calculate and evaluate results.
Successful completion of assigned training.
Make detailed observations in support of Alert, Action and OOS result investigations.
Participate in writing and revising SOP’s.
Ensure lab areas are clean, safe and properly stocked.
Effectively demonstrate an understanding of cGMPs and application to specific responsibilities:
Work compliantly & independently under supervision and direction.
Follow accurate written procedures for testing of in-process and final product samples.
Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines.
Perform maintenance on basic laboratory equipment.
Basic Qualifications:
One of the following:
High School Diploma with minimum of 4 Years of relevant industry experience.
Associates Degree with 2-4 Years of relevant industry experience.
Bachelor’s Degree with 0-2 Years of relevant industry experience.
Proficient with Microsoft Office tools such as: Word, Excel & PowerPoint
Preferred Qualifications:
1 Year Experience in GMP lab environment.
Proficiency in Microsoft Office tools such as: Word, Excel & PowerPoint.
Experience with lab-based data management systems.
Experience in a Quality Control Laboratory.
Experience with Environmental Monitoring, including Water Testing.
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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