US-CA-Corona: Quality Assurance Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99671677_Quality_Assurance_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 28-Sep-2010

Quality Assurance Engineer

• Identifies deviations from SOP’s and cGMP’s. Directs the proper
investigation, resolution and conditions of approval. • Directs the QA
function related to sampling of raw materials, in-process and finished
goods, sampling and inspection of labeling testing packaging
components, statistical inspections in- process, in-process
segregation of suspect/rejected material and maintenance of approved
supplier lists. • Directs the management of systems for deviations
including identification, investigation, resolution, tracking and
follow-up deviations. Approve deviation investigations and define
conditions for approval. • Maintain a system for security of cGMP and
other documents to comply with company and regulatory record retention
requirements. • Direct the Quality Assurance functions to ensure that
all laboratory, production and raw material supplier records are
audited in compliance with company and regulatory requirements release/
reject raw materials, packaging components and finished product based
on these audits. • Interfaces with state and federal regulatory
agencies. Participates in Corporate, state, FDA and third party
compliance audits. • May be responsible for the timely and compliant
investigation and closure of product complaints from the field. •
Makes recommendations relating to potential methods in resolving
production and packaging quality systems. • Analyzes, prepares and
monitors department budget. • Current cGMP’s, SOP’s, FDA, EMEA and
other regulatory requirements. • Personal computer hardware and
software applications • Business English usage, spelling, grammar and
punctuation • Principles and practices of managing Quality Assurance
programs • Principles of mathematical and statistical computations •
Chemical analysis and instrumentation • Principles and practices of
budget preparation and administration • Pharmaceutical principles and
practices and their application • Recruiting, interviewing, and
selecting applicants in accordance with established employment
practices and methods • Managing, directing and coaching a team of QA
and QC professionals in the investigation and resolution of
deviations. • Working with regulatory agencies through the audit
review process.


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

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