|Zosano Pharma, Inc. is a private specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. Zosano Pharma is built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common commitment to work toward achieving the Company? goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success.
The Quality Assurance Specialist in the QA group serves as a primary QA reviewer of Manufacturing batch records, QC test data and other documentation supporting GMP operations and product disposition. Additionally, the position will provide support for the document control system and training program.
Reviews executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition
Assists in maintaining the document control system. Duties include but are not limited to supporting document change control activities, document generation, tracking and distribution for review, approval and filing.
Reviews QC data generated from manufactured product , raw materials and intermediates
May review and approve validation protocols, reports and validation deviations
Reviews SOPs for compliance to internal procedures
Independently interacts with other groups to proactively address compliance concerns and resolve problems
May participate on cross-functional compliance improvement projects
May assist in performing internal audits
Will be responsible to work the second-shift to support Manufacturing and QC activities
Will be responsible to be on-call occasionally to provide off-hours support.
BS in Chemistry, Biology or other relevant discipline.
4+ years QA or equivalent experience.
Prior hands-on experience establishing and/or maintaining a document control system is required.
Prior working experience maintaining training program activities preferred.
Strong understanding of cGMP? and concepts in several quality systems.
Understanding of basic scientific/technical concepts.
Good analytical skills.
Clear, concise writing skills and good verbal presentation skills.
Excellent organizational skills and attention to detail.
Ability to interact constructively and efficiently with co-workers
Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Demonstrates strong understanding of procedures and methods for review function.
May participate on project teams and actively participates in cross-functional compliance improvement projects
Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
State or Province