Senior Quality Assurance Engineer Lead
Skills
CapasComputerized System ValidationGxpManufacturing OperationsPharmaceutical ManufacturingProduct RequirementsQuality Assurance
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- B.S. degree and 6+ years of GxP pharmaceutical manufacturing experience
- 2+ years of quality assurance experience
- Knowledge and application of CFR’s and cGMP’s
- Experience with FDA and EU regulations and US/international regulatory agency inspections
- Experience leading internal audits and providing closure reports
- Experience with commissioning, qualification, and validation to meet FDA and other health authority requirements
- Experience with deviations, CAPAs, and Change Controls
- Experience reviewing/authoring standard operating procedures and partner with operations on product investigations
- Experience leading people
- Excellent oral and written communication skills with technical writing experience
- Ability in long-term project planning, team building, budgeting, and operational excellence
Nice to have
- B.S. in Engineering, Chemistry or Biochemistry
- Sterile manufacturing experience preferred
Day to day
- Responsible for design, construction, validation, maintenance, and compliance of facilities, systems, and processes at Carlsbad RLT manufacturing site
- Ensure Quality and Compliance aspects of design and work with Engineering, Manufacturing Operations, and consultants
- Provide strategic quality input on translating commercial product requirements into technical solutions and oversee Computerized System Validation Lifecycle