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QA Manager

Location:Fremont, CA
Employment Type:Full Time
Department:Zosano Pharma
Description:Zosano Pharma, Inc. is a private specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. We have developed a user-friendly, simple, and needle-free transdermal delivery system consisting of a patch and reusable applicator - that is proven capable of delivering a broad range of compounds, including peptides, proteins, small molecules and vaccines. This innovative technology is enabling us to develop products with significant commercial potential both independently and in collaboration with strategic partners. We aim high. Our lofty goals are built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common vision and are committed to achieving the Company's goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success. We are seeking individuals who want to make a mark in their profession and who are eager to grow. If you aspire to lofty goals and desire success, you've come to the right place. Read on...
Duties:• Report to and working with Director QA/QC.
• Responsible for leading the 1st and 2nd shift QA team to support in-process, final product and raw material manufacturing and testing activities.
• Plan, coordinate and direct QA activities associated with Zosano products and systems
• Establish and maintain quality assurance programs, procedures, and controls
• Oversee the quality and timely review of test and study results and reports and batch records.
• Review and approve study protocols, reports, SOPs, batch records and other assigned quality documentation.
• Oversee the quality of validation/qualification activities.
• Perform and support internal and external quality audits when needed.
• Represent the QA function in interdepartmental project teams.
• Review lab investigation, OOS and OOT investigations, deviation reports and CAPA.
• Lead, supervise, mentor and provide technical support to QA staff.
• Ensure quality system requirements are followed and maintained and all personnel within team and company comply with cGMP requirement.
Qualifications:• Ability to work independently and as part of a team; ability to motivate self and others with limited supervision is required.
• Ability to take initiative and prioritize tasks; good time-management, problem-prevention; and problem-solving skills are required.
• Good written, computer and communication skills are required.
• BS or MS degree in a Chemical or Biological discipline or equivalent is required.
• Minimum of 5 years of QA experience and 2 years supervisory/management experience in QA is required.
• Demonstrated experience in performing investigations and risk assessments is required
• Demonstrated experience in preparing reports and presentations for peer, upper management and interdepartmental review is required.


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