| Job Description | Required Education:
Bachelors Degree
Description:
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 change management, CAPA, document control systems and training program.
Responsibilities:
• Reviews executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition
• Manages and tracks change control and CAPA documentation for timely completion, compliance, and effectiveness to support manufacturing operations and 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 aseptically 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
• Will participate as the QA representative in cross-functional meetings, compliance improvement projects and internal and external audits
• Will assist in performing internal audits
• May be responsible to work the second-shift to support aseptic Manufacturing and QC activities
• Will be responsible to be on-call occasionally to provide off-hours support
Requirements
• 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 preferred
• Prior working experience maintaining training program activities preferred
• Prior working experience managing change control and CAPA activities preferred
• Strong understanding of cGMP’s and concepts in multiple quality systems (drug, device, combination products, aseptic manufacturing) is preferred |
| | Company | | Zosano Pharma | Job Code | | State or Province | | California | | |
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