US-Hillsboro-Oregon: Senior QA Specialist
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99668619_Senior_QA_Specialist.htmlTo see other opportunities, please visit
http://sqa.fyicenter.comDate: 16-May-2011
Senior QA Specialist
Job Duties/Responsibilities: · Partner with support groups to lead
cross-functional evaluationand resolution of product quality impacting
issues.· Independently manage all levels of discrepancies including
leadingcomplex investigations. Provide guidanceto other members of the
MQA group regarding complex discrepancies.· Work closely with QA Site
Support, Quality Engineering, and QAValidation to assure alignment
between Quality Systems including, but notlimited to, Discrepancy
Management, CAPA, Validation, and Risk Management.· Foster an
environment of collaboration with Production andtechnical support
groups· Review and approve commercial manufacturing batch records
insupport of lot disposition. · Provide direct Manufacturing QA
support during internal and externalregulatory inspections, including
acting as SME on Quality Systems related toMedia Fills and
Environmental Qualification.· Work on the production line in support
of routine operations.· Multitask and manage competing priorities
while meeting technicaltransfer timelines.· Collaborate with QA Site
Support to assure a consistent state ofinspection readiness.·
Identify, design, and implement process and system improvements.·
Serve as the Quality representative on cross-functional and multi-
site teams. Act as key liaison within corporate network on key quality
systems.· Review and approve documents for commercial processes.·
Provide risk-based decisions to assure effective use of resources.·
Provide input to the development of personal performance goals
anddepartmental objectives.· Collaborate with Management to establish
and meet targets and timelines.· Ensure that the proper policies and
procedures are in place andbeing followed. Act as a key point
ofcontact within MQA regarding interpretation of governing documents
(bothinternal and external).
Qualifications: Education, Experience, Knowledge and Skills: (Minimum
requirements) * B.A. or B.S. degree (preferably in Life Science) and
at least eight years experience in the pharmaceutical or
biopharmaceutical industry, or an equivalent combination of education
and experience * Sound knowledge of aseptic processing * Sound
knowledge of cGMPs or equivalent regulations * Ability to interpret
Quality standards for implementation and review * Ability to make
sound decisions about scheduling, allocation of resources, and
managing priorities * Ability to communicate clearly and
professionally both in writing and verbally * Flexibility in problem
solving, providing direction and work hours to meet business
objectives DIVISION: Quality Biochem
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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