QC Manager Zosano Pharma
THIS JOB HAS EXPIRED 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?
Report to and working with Director QA/QC.
Responsible for leading the 1st and 2nd shift team of to support in-process, final product and raw material testing during manufacturing activities.
Oversee the quality and timely delivery of test and study results and reports.
Write and/or review study protocols, reports, SOPs and other assigned documentation.
Oversee the quality of validation/qualification activities.
Perform and support internal and external quality audits when needed.
Represent the QC function in interdepartmental project teams.
Perform lab investigation, OOS and OOT investigations; prepare deviation reports and CAPA.
Lead, supervise, mentor and provide technical support to QC staff.
Ensure quality system requirements are followed and maintained and all personnel within team comply with cGMP requirement.
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 Chemistry, Biochemistry or equivalent is required.
Minimum of 5 years of QC laboratory experience and 5 years supervisory/management experience in analytical chemistry Quality Control is required.
Demonstrated experience in performing lab investigations, OOS and OOT investigations is required
Demonstrated experience in preparing reports and presentations for peer, upper management and interdepartmental review is required.
Advanced knowledge of HPLC and familiarity with EMPOWER software are preferred.
Knowledge of analytical techniques, such as GC, FTIR, UV, KF, are preferred.
Experience on reviewing environmental monitoring, microbiological and endotoxin data are preferred.
||34790 Ardentech Court |
Fremont, CA 94555
THIS JOB HAS EXPIRED