Quality Control Analyst I

Job Description
Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Description
Thsi position is an off-shift role Saturday and Sunday 7AM to 530PM, Monday and Tuesday- 1Pm to 1130PM

Quality Control Chemistry is responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for cGMP operations. Various techniques are utilized in Quality Control including HPLC, GC, Gel Electrophoresis and multiple types of spectrophotometry. Additional functions include stability testing, assay transfers and the qualification of new instrumentation utilized in the Quality Control laboratory.

Position Summary
This position is responsible for performing routine testing of in-process samples, stability samples and final products in accordance with SOPs for product release.

Core Responsibilities

Perform UV-Vis spectrophotometry, HPLC and Gel assays for in-process and final product samples.

Review of QC Data for compliance to procedures and specifications.

- Calculate and evaluate results.

Effectively demonstrate an understanding of cGMPs and application to specific responsibilities:

Follow accurate written procedures for testing of in-process and final product samples.

Provide input to technical composition of operating documentation.

Work independently under general supervision and direction.

Work in compliance with CGMPs.

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


Qualifications
Basic Qualifications:

B.A. or B.S degree in life or physical sciences is required with 0-2 years experience in a cGMP environment.

Preferred Qualifications:

1 year experience in a cGMP lab environment

Proficient in Outlook and Microsoft Word and Excel.

Experience using UV/VIS Spectroscopy, Karl Fisher Titration, Gel Electrophoresis, and HPLC (DIONEX and AGILENT/HP).

Company

Genzyme

Job Code

State or Province

Massachusetts

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