Senior Specialist, Quality Operations

Role Summary

The Senior Specialist, Quality Operations is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution.

Responsibilities

• Support various Chemistry, Manufacturing and Controls (CMC) projects
• Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
• Interface with CMOs/CTLs to provide QA oversight of routine manufacturing and packaging activities
• Perform product disposition/batch release
• Review and approve master batch records and executed batch records
• Review and approve quality control records (e.g., COAs, specifications, analytical protocols and reports, stability protocol and reports, etc.)
• Review and approve manufacturing records (e.g., validation/development/transfer protocols and reports etc.)
• Review and approve quality events (e.g., deviations, change controls, CAPAs and complaints)
• Ensure timely complaint initiation, investigation/analysis and closure
• Support quality audit of suppliers, CTLs and CMOs
• Other duties as assigned

Qualifications

• BA/BS or master‚Äôs degree in science, engineering or related field
• 6+ years in Quality Assurance
• Knowledge in the application of 21CFR211, global cGMP regulations and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery and control of pharmaceutical products
• Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
• Ability to work independently and communicate effectively with project team members, management groups and suppliers
• Works well in a project team environment with solid problem analysis and decision-making ability
• Ability to author, review and approve SOPs and other controlled documentation for compliance with applicable regulations
• Advanced Microsoft Office application skills (Word, Excel, PowerPoint)
• Travel required

Skills

• Analytical chemistry
• Pharmaceutical manufacturing technologies
• QA oversight and investigations
• Documentation control and SOP authoring
• Cross-functional collaboration

Education

• BA/BS or master‚Äôs degree in science, engineering or related field

Additional Requirements

• Authorized to work in the United States on a full-time basis