US-CA-Corona: Quality Assurance Engineer
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.
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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