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US-MA-Cambridge: QA Associate I
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 17-Apr-2008
QA Associate I
Primary Duties & Responsibilities:
# Ensuring the manufacture of clinical material consistent with approved batch records, SOPs and relevant regulatory requirements
# Assisting with tech transfer to commercial CMO
# Perform QA review and ensuring appropriate completion of batch records and QC data supporting GMP manufacture
# Representing QA in Change Control review and approval
# Representing os QA in deviation and investigation resolution with CMOs and QC, and contract laboratories
2. QA participation and oversight of clinical manufacturing activities, including, but not limited to:
# Support process and analytical development
# Support validation activities as required
# Generation and approval of batch records
# Perform QA review and ensuring appropriate completion of batch records and QC data supporting GMP manufacture
# Vendor qualification
3. QA participation and oversight of clinical development program, including, but not limited to:
# Support process and analytical development
# Generation and approval of batch records
# Perform QA review and ensuring appropriate completion of batch records and QC data supporting GMP manufacture
Qualifications:
Minimum Requirements
# Requires a bachelor's degree and 2-4 years of experience in the field of Biology, Chemistry or related Science
# Familiar with a variety of quality assurance concepts, practices and procedures
# Performs a variety of complicated tasks
# A wide degree of creativity is expected
# Must be able to communicate effectively with technical/engineering staff
Desired Requirements
# Strong written and verbal communication skills, strong work ethic and proven track record of working successfully in teams.
# Experience in a GMP environment a plus
For more information, please write to us.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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