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Quality Assurance Engineer

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POST DATE 8/10/2016
END DATE 11/20/2016

Biotest Pharmaceuticals Corporation Boca Raton, FL

Boca Raton, FL
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


This position will ensure Quality Systems Compliance via tracking and trending and leading investigations and process improvement projects. Support project management activities for continous improvements. Ensure current Good Manufacturing Practices (cGMP) and regulatory compliance as defined in government regulations including, but not limited to 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures. Lead or participate in initiatives to improve quality systems for potential compliance gaps or trends. Track progress and timely completion of deviation investigations and CAPAs. Review, assess, and approve deviation investigations, CAPAs, Change Controls, equipment qualification, and process validation documentation. Lead or participate in cross-functional teams to resolve investigations using Root Cause Analysis methodology. Assist operating departments in the identification of appropriate root causes and implementation of effective corrective / preventive actions. Lead or participate in cross-functional teams to conduct risk analysis, as needed, to identify root causes for process and system failures, and analyze changes under consideration. Assist operating departments to identify gaps in processes and systems to improve compliance with cGMPs. Review and/or provide quality impact assessments for quality system records. Provide quality oversight for production and guidance for issues that may arise during production activities. Provide oversight for CMO and related documentation and quality records. Assist in management and implementation of process improvement projects. Provide training and coaching to junior level staff for deviation investigations, CAPAs, change controls, and quality oversight. Oversee job-specific departmental (QA Product Release) training to ensure program appropriateness and compliance. Assess programs for effectiveness and initiate improvement plans where necessary. Identify needs for and coordinate targeted training required based on trends identified in tracking of quality system performance.