Software Quality Assurance Director directs and oversees the implementation of policies and procedures for the software quality assurance function. Evaluates and monitors tools, methodologies, and automation to ensure effective testing and identification of defects. Being a Software Quality Assurance Director oversees user acceptance, alpha, and beta testing efforts. Requires a bachelor's degree. Additionally, Software Quality Assurance Director reports to top management. The Software Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Software Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP controlled documentation system and for providing the various *** departments the documentation that is necessary to perform cGxP activities. Other responsibilities include auditing existing documentation, reporting document trends to management, and managing electronic document systems.
Process requests for document changes utilizing the EDMS
Process document Special Handling requests
Provide department metrics to management
Participate in documentation audits
Process logbook requests and perform routine audits
Process laboratory notebook requests
Responsible for maintaining Archive Room: filing, assisting customers
Identifies improvements with group-level impact
Manages assigned work and takes on additional responsibilities
Involved with other projects as required
Preferred experience in auditing documentation
Proficiency in MS Word & MS Excel. Livelink and MS Access a plus
Ability to communicate clearly and effectively through verbal and type-written correspondence
Legible penmanshipOrganizational skills to coordinate multi-discipline projects
Experience in participation in regulatory inspections a plus
Understanding and familiarity with FDA and European regulatory requirements, guidelines
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0 Software Quality Assurance Director jobs found in Petaluma, CA area