US-CA-Corona: Quality Assurance Engineer
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Quality Assurance Engineer
Identifies deviations from SOPs and cGMPs. 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 cGMPs, SOPs, 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.
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