Sr. Quality CMO Specialist

How will you make an impact?

Senior Quality Assurance Specialist will provide quality support for Glaukos Drug product manufacturing (primary or secondary or distribution) at External Contract Manufacturing Organizations (CMOs). The Sr. Specialist will contribute and support the completion of milestones associated with specific projects and support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's as well as Batch release activities. Additionally, the individual may manage data tracking systems to maintain metrics and trends. The individual will work closely with internal cross-functional impacted areas, such as Supply Chain Operations and logistics, Internal Quality Assurance and CMC as well as external Vendors. Under the guidance of the Manager of Quality Assurance this individual will be the point person from the quality organization for supporting all commercial and clinical supply chain external quality operations and activities associated to finished goods manufacturing through final finished goods distribution

What will you do?

• Sr. QA Specialist will perform all responsibilities in accordance with company policies, procedures, and regulations.
• Review, approve and disposition from drug substance to finished goods and labeling batch record
• Provide quality oversight/support to CMO and distribution vendors
• Review, investigate and report temperature excursions and manage product impact assessment based on data
• Assist in developing and updating procedures to support commercial/clinical supply chain and distribution operations
• Track batch release metrics as well as vendor-based deviations
• Manage Quality Systems including change controls, deviations and complaints within Glaukos systems as well as tracking those at CMOs
• Review and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow ups
• Review client specific standard operating procedures and controlled documents issued by the CMOs
• Provide QA support for technology transfer and improvement of existing manufacturing processes.
• Develop and maintain metrics for key quality performance indicators for cross-functional visibility
• Manage Supply Chain Quality deliverable timelines and provide updates to internal and external customers on a regular basis
• Support contract manufacturing sites and perform Person-in-Plant duties as needed
• Support validation activities including validation protocol approvals and all other associated Quality functions
• Partner with External Manufacturing Operation to execute technical transfer deliverables
• Develop and Maintain Quality Technical Agreements and annual product summaries
• Ability to prioritize and work independently with minimal supervision and an ability to escalate issues as needed
• Requires approximately 15% travel (domestic)

How will you get here?

• Bachelor's Degree Required, Master's Degree Preferred
• Minimum of 5-8 years pharmaceutical quality, GMP QA/QC/ compliance or laboratory experience
• Excellent working knowledge of Quality Systems, GMP-related requirements and ICH guidelines.
• Experience in the pharmaceutical industry with a strong analytical and quality background In-depth knowledge of the industry's standards and regulations (i.e. 21CFR 210/211, 820, ISO 13485)
• Strong documentation skills, attention to detail and accuracy
• Excellent interpersonal skills and the ability to communicate well orally and in writing
• Experience with product release, NCMRs, product complaints, and deviations
• Batch record reviews for first in plant manufacturing campaigns
• Previous working experience with clinical, commercial and multiproduct facilities
• Good understanding of CMO operations
• Good understanding of analytical method qualification/validation and drug substance/drug product stability requirements per ICH
• Demonstrated teamwork and ability to work in a team environment
• Ability to multi-task in a dynamic environment with changing priorities

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