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cGMP Compliance Specialist
JOB TITLE >> Compliance Specialist
LENGTH OF ASSIGNMENT >> July 01, 2009 through January, 2010
HOURS PER WEEK >> 40
DAYS PER WEEK >>
HOURS PER DAY >> 8
SHIFT START TIME >> 8:00
FIRST DAY SHIFT START TIME >> 8:00
SHIFT END TIME >> 17:00
-- DUTIES AND RESPONSIBILITIES
DUTIES >> The QA Compliance Specialist will support activities to ensure site GMP and general compliance readiness to support major biotech manufacturing company with a cGMP campus based in Allston. The specialist will be part of the Compliance Team that works with Bulk and Fill Finish Quality Assurance, management and peers in other functional areas, primarily Therapeutic Manufacturing, Quality Control, Regulatory Affairs and Corporate Compliance.
The position contributes to the assurance of Allston inspection readiness in alignment with global good manufacturing practices, regulatory compliance requirements and current industry/Genzyme policy and guidance.
SKILLS >> Work with Quality and Manufacturing to investigate deviations, establish the root cause and identify and implement corrective and preventive actions.
EDUCATION >> BS Degree with a minimum of 5 years QA/Technical support experience working in a Biotech/Pharmaceutical company. Solid understanding of cGMPs, root cause analysis techniques and assessing corrective/preventive action effectiveness. Good understanding of global regulations (US, EU, Canada , JP, Australia ) pertaining to compliance quality programs. Must be able to read and interpret complex documentation for compliance with procedures, standards, and regulations. In addition, have sound report writing experience.
Preferred Qualifications:
Industry experience within manufacturing, deviation/investigation and or other support function areas. Excellent written and verbal communication skills are required. Great attention to detail.
Thanks,
Kathleen McTeague
Senior Staffing Consultant
Randstad Life Science Staffing
617-354-7215
kathleen.mcteague@us.randstad.com
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Salary: $38 to $45 Per Hour
Position Type:
Contractor, Temporary
Ref Code: Compliance Allston |
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