Senior Quality Assurance Manager

Company: Azer Scientific
Location: Morgantown
Posted on: August 7, 2022

Job Description:

Position SummaryThe Senior Quality Assurance Manager is accountable for managing QA across different applications and different teams, ensuring successful QA for all major projects, enhancements, and maintenance changes. Implements strategic initiatives by determining methods to obtain tactical results within QA. Manages the daily activity of the QA department and QA staff. Responsible for continual improvement of Quality Management Systems (QMS), ensuring compliance with ISO 13485:2016.
Duties and Responsibilities --- Own the Quality Assurance testing for at least one program or business channel with numerous projects running concurrently--- Lead QA initiatives including supervising and managing QA team and contributing to the testing effort in a hands-on role--- Work with the QA Manager to enhance QA standards, technologies, and approaches--- Act as key point of contact for all QA services, internally and externally--- Manage all aspects of QA to ensure raw materials and products meet company standards--- Develop, review and audit SOPs--- Independently create and review GMP documentation including SOPs, Annual Product Quality Reviews, Risk assessments, Supply chain map and reports as required--- Provide support for deviation, investigations, including root cause analysis, and corrective & preventive action (CAPAs) proposals and initiatives--- Accurately complete and review inspection and testing results; confirm compliance to established requirements--- Initiate and lead actions to prevent the occurrence of nonconformities relating to product, process, and QMS--- Ensure the QMS is maintained through appropriate audits, tests, inspections, and surveys--- Develop systems to measure performance against established standards --- Evaluate performance (in relevant areas) according to standards and take necessary action to advise and communicate according to performance levels--- Establish and implement communication strategy for the improvement and awareness of quality issues across all departments--- Report goals on performance against standards--- Manage internal or supplier audits--- Contribute to executive policy and strategy--- Perform other duties as assigned
Skills--- Strong leadership, time-management, and organizational skills --- Strong knowledge of quality standards--- Proactive, strong-minded, and assertive--- Ability to make considered decisions and to communicate them effectively--- Good numerical skills and an understanding of statistics
Education --- Bachelor's degree in business, engineering, or equivalent experience--- Certified Quality Auditor (CQA) is required --- Six Sigma certification, preferred
Requirements--- 7+ years of related new business development--- 5+ years Lead / Manager of QA--- A solid foundation in quality assurance processes and procedures--- Experience in clinical, research, or industrial laboratory industry, strongly preferred--- Microsoft Office Suite. Advanced knowledge of Excel--- Proficient in NetSuite or similar CRM and ERP--- Ability to lift materials and product up to 50 pounds--- Require the use of safety equipment to include but not limited to eye safety glasses, lab coat, hearing protectors, work boots

Keywords: Azer Scientific, Reading , Senior Quality Assurance Manager, Executive , Morgantown, Pennsylvania