QUALITY CONTROL ANALYST IIBookmark This
DescriptionQUALITY CONTROL ANALYST II-33527
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.
Quality Control Analyst II
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/MS, HPLC, GC, Rheology, Continuous Flow Analyzer and multiple types of spectrometry. Additional functions include raw materials testing, stability testing, assay transfer and the qualification of new instrumentation utilized in the Quality Control laboratory.
Responsibilities of this position include, but are not limited to:
- Responsible for conducting routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures.
- Deliver timely, accurate and compliant sample analyses following standard operating procedures in a cGMP laboratory to support manufacturing. Primary analytical techniques are UV, GC, FTIR, and HPLC.
- Compiles data for documentation of test procedures and prepares reports.
- Reviews QC data for compliance to procedures and specifications, and reports abnormalities.
- Enter and review data in LIMS.
- Make detailed observations in support of OOT and OOS result investigations.
- Revises and updates standard operating procedures and protocols as needed.
- Utilizes knowledge of good manufacturing practices and good laboratory practices on a daily basis.
- Keeps abreast of new technology and make recommendations for test method and testing capability enhancements.
- Participate and perform special studies projects assigned to Chemistry.
- Participate in the qualification of equipment, methods, and processes.
- Perform other additional job related duties as required.
- Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.
- Ensure labs are clean and safe (in compliance with cGMP) and properly stocked.
- Perform general maintenance of lab equipment. M*
- Occasional weekends may be required
- Bachelors degree in chemistry from an accredited college or university required
- A minimum of 2 years' experience in a cGMP quality control laboratory
- Experience with Standard Laboratory Practices, GMP, ISO, USP EP
- Must be organized and detail oriented
- Laboratory skills -- computer controlled UV, GC, FTIR, and HPLC, workstation software (Empower), office software (MS Excel, MS Word, etc), LIMS database and compliance level record keeping
- Prior experience in device development or pharmaceutical environment preferred
- Good communication skills
Job : Quality
Primary Location : United States-New Jersey-Ridgefield
Job Posting : Jan 29, 2014, 3:28:35 PM
Shift : Day Job
Job Type : Regular
Employee Status : Regular