Manager, Quality Assurance

Company: Alexza Pharmaceuticals, Inc.
Location: Mountain View
Posted on: November 22, 2021

Job Description:

Responsibilities * Manage QA operations to support manufacturing. Activities include but are not limited to: incoming materials and finished product sampling, API sampling, production line clearance, issuance of batch records and labels, review of executed batch records, perform ERP system inventory transactions * Assist in material and product lot disposition * Responsible for the corporate GMP training program * Manage QA programs including but not limited to: QA retains, deviations, CAPA, change control, MRB, complaint handling * Perform internal audits * Participate in regulatory inspections * Prepare and trend quality metrics for presentation in Management Review meetings * Prepare annual Product Quality Review reports * Manage QA document and record control system (both electronic and paper based) including the oversight of the receipt, maintenance, approval, and distribution of controlled documents * Ensure SOPs are periodically reviewed for relevance and accuracy * Assist with the development of quality system procedures * Revise departmental procedures, as needed * Participate in supplier management including supplier reassessment, supplier audits, supplier audit schedule * Identify and participate in implementing proactive quality improvements and take on additional tasks as assigned * Organize QA electronic folders * Supervise QA personnel and provide training as applicable Skills required * Strong written and verbal communication, organizational and prioritization skills * Excellent attention to details skills * Ability to handle multiple priorities in a dynamic environment with attention to detail and follow through * Ability to work in a team environment and collaborate with others throughout the organization * Ability to maintain a flexible and a customer-oriented approach to problem-solving Education and Experience * BS/MS in life sciences or related discipline * Five to ten years of experience in the pharmaceutical or medical device industry required * Proven track record of effective management * Proficiency in MS Office applications * Experience in Electronic Document Management System is a plus * Experience in GMP audits of vendors, contract analytical laboratories and contract manufacturers required Physical Requirements * Prolonged periods of sitting at a desk and working on a computer * Must be able to lift up to 15 pounds at times * Must be willing to travel

Keywords: Alexza Pharmaceuticals, Inc., Mountain View , Manager, Quality Assurance, Executive , Mountain View, California