| Job Description | Description Alexza Pharmaceuticals, located in Mountain View, CA, is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, including agitation, acute repetitive seizures and insomnia. Alexza's products are based on the Staccato® system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.
ADASUVE® (Staccato loxapine) is Alexza’s first approved product, which was approved by the U.S. Food and Drug Administration in December 2012 and by the European Medicines Agency in February 2013. Grupo Ferrer International, S.A. is Alexza’s commercial partner for ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. The commercial launch of ADASUVE is planned for the third quarter 2013 in the U.S. and Europe.
We have an exciting opportunity for a Quality Assurance Specialist II for our team. This person will work closely with our Quality staff to transition our organization to commercial readiness.
Responsibilities
· Provide QA presence on the manufacturing floor to ensure compliance with the relevant SOPs and cGMP
· Perform line clearance
· Provide Quality support for issues arising on the floor and guidance to Manufacturing
· Assist manufacturing personnel with the initiation of discrepancies
· Assemble and review executed batch records associated with Alexza Products
· Review variety of cGMP documentations
· Review QC test results for component release
· Perform API and final product sampling
· Conduct inspection of reserve samples
· Participate in internal audits as needed
· Prepare and trend quality metrics
· Revise departmental procedures as needed
· Alert management of product quality trends and significant observations
Requirements Preferred Skills:
· Strong attention to detail
· Knowledge of cGMP documentation practices and cGMP compliance for pharmaceutical and medical device products
· Familiarity with manufacturing equipment and processes
· Ability to work in controlled, classified environment, strong communication, interpersonal and negotiating skills
· Ability to respond well to tight timelines and resource constrains and handle multiple priorities effectively
· Ability to exercise judgment within broadly defined practices and policies to evaluate and solve problems; decisions may have impact on product
· Ability to interact at peer level to influence outcome and coordinate activities cross-functionally
· Ability to work on problems requiring in-depth evaluation of various factors
Education
· BS/BA in physical/chemical/biological sciences with 5-8 years GMP experience
We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. |
| | Company | | Alexza Pharmaceuticals | Job Code | | State or Province | | California | | |
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