US-Hillsboro-Oregon: Senior QA Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 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

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Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com