Compliance Specialist Senior Day Rotating
Genzyme - Framingham, MA

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Compliance Specialist Senior-Day Rotating-32677

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 .

THIS POSITION IS ROTATING DAY 12 hour shift (645AM- 715PM) every other weekend required.

This individual will report to the Quality Assurance Supervisor for the 76 New York Avenue Facility and will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with Manufacturing, Engineering, Facilities and Validations.

RESPONSIBILITIES:
  • Draft and revise procedures as required
  • Review and approve batch production records, manufacturing logs,
and QC test results in support of product release
  • Participate in the internal audit / walk-thru program
  • Ensure that documentation and operations meet established
requirements of cGMP's, internal SOP's and company policies

Qualifications
BASIC QUALIFICATIONS
High School Diploma or GED and 2-4 years Quality and/or Operations experience in a cGMP Manufacturing environment or equivalent.
  • Strong computer, verbal and written communication skills.
  • Strong technical writing skills.
  • Experience in quality systems.
PREFERRED QUALIFICATIONS
Bachelor's Degree in a scientific field
Effective time management, attention to detail, organizational skills, teamwork and collaboration
Experience in bio-pharmaceutical industry.
Demonstrated competence in problem solving methodology.
Experience working in an environment of operational excellence.
Experience participating and/or leading cross-functional project teams
  • M
Job : Quality
Primary Location : United States-Massachusetts-Framingham

Job Posting : May 8, 2013

Shift : Rotating
Job Type : Regular
Employee Status : Regular

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