Position Title: Quality Assurance Scientist
This is a highly technical quality position responsible for decision-making on product issues, design and development requiring critical analytical thinking. The desired candidate has a strong scientific background, knowledge of quality processes, attention to detail and strong organizational and communication skills. Roles and
Responsibilities: - Responsible for Technical Decision-Making for Product Issues - Performs detailed data review. - Participates and reviews in risk assessment for products and processes. - Supports risk analysis process for technical accuracy for various QMS, e.g., nonconformances, investigations, CAPAs, etc. - Represents Quality in Design and Development including process changes. - Provides key technical guidance and oversight to Design and Development process including design change control. - Evaluates changes orders - Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards. - Evaluates and edits Technical Protocols and Reports - Performs critical review of documentation for qualification, verification, and validation activities. - Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities. - Assures design and development, and manufacturing operations are performed in compliance with QMS as well as domestic and international regulations. - Provides scientific approach and Quality Assurance direction to the approval of the QMS documents such as batch records, protocols, procedures, qualification, and validation reports.- Enforces critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. - Provides scientific input into investigations using a systematic approach for the opportunities identified to ensure root cause and CAPAs are aligned. - Assists management during internal and regulatory agencies inspections. - Performs trend analysis to provide recommendations to improve the process and/or product quality. - Supports the Annual Product Review elements for Quality events of manufacturing. - Participates as quality representative or liaison in site projects.