To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99684704_QA_Associate.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 27-Dec-2007
QA Associate
Primary Duties & responsibilities:
1. - 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 Altus QA in Change
Control
review and approval - Representing Altus QA in deviation
and
investigation resolution with CMOs and QC, both Altus and
contract
laboratories
2. - 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. - 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
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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