Sanofi Group QC Principal Analyst- Rotating Nights in Framingham, Massachusetts

Department Description

Quality Control Microbiology supports manufacturing activities at Genzyme's Framingham Campus by detecting, quantifying, and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environmental 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.

Position Summary

Contribute to general operations and testing of the QC Microbiology laboratory. The QC Principal Analyst works independently to collect and process samples in a timely manner and routinely assumes a leadership role to perform microbiological testing and/or validation in accordance with SOP’s and cGMP regulations, review laboratory assay documentation for accuracy and timeliness, participate with the team to meet the group goals, employ in-depth technical knowledge and define, strategize and implement laboratory studies.

The hours of this position are 6:45pm-7:15am rotating days.

Core Responsibilities

Collect and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.

Perform Water, Steam, and Critical Utility collection as well as associated testing.

Perform Biological Indicator Testing.

Perform Environmental Monitoring.

Perform Endotoxin Testing (Gel Clot and Kinetic Turbidimetric).

Perform Bioburden Testing of In-Process products, buffers, and water.

Receive manufacturing samples into the QC Lab as well as sample retain disposal.

Troubleshoot assay and instrument problems with Laboratory Supervisor.

Enter and review data in LIMS.

Oversee testing occurring on shift.

Perform safety and operational lab audit.

Perform general maintenance of lab equipment.

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

Ensure GMP compliance of all activities performed.

Participate in writing and revisions SOPs, protocols.

Assist in the development and optimization of testing methods.

Maintain log books related to inventory and equipment.

Ensure labs are clean and safe (in compliance with cGMP) and properly stocked.

Make detailed observations in support of Alert, Action, and OOS result investigations.

Participate in the qualification of equipment, methods, and processes.

Participate and perform special studies & projects assigned to microbiology.

Perform ELISA testing.

Perform other additional job related duties as required.

Perform plate reading, streaking, gram staining, microbial identification.

Perform routine Quality Control testing of in-process and final products in a cGMP lab for release.

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

Provide training to less experienced staff.

Participate in authoring complex and explicit documentation (protocols and technical reports)

Involvement in equipment or facility qualifications (IQ/OQ/PQ) and method validation.

Represent QC in internal and external audits as required.

  • Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

Leadership Qualifications

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

Being honest and treating people with respect and courtesy.

Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.

Action as a role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications

Bachelor’s Degree in Life Sciences discipline and 8 years of experience in CGMP lab environment, OR Master’s Degree in Life Sciences discipline and 5 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.

Familiarity with USP and global compendial regulations.

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

Experience troubleshooting of assay and equipment issues.

Working knowledge of aseptic technique.

Preferred Qualifications

Proficient in Outlook and MS Word, Excel and lab based data management systems.

Special Working Conditions

Must be able to lift 40lbs.

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

Nights, weekends and holidays may be required.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. 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 “at will” employment relationship.

Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. Learn more at www.sanofigenzyme.com.

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.

Genzyme Corporation (a Sanofi company) 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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life