Sr Specialist/Manager – Quality Operations

Sr Specialist/Manager – Quality Operations

Requirements

• 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
• Work 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)

Responsibilities

• Act as Quality lead and 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
• Lead and support quality audit of suppliers, CTLs, and CMOs
• Other duties as assigned

Preferred Qualifications

• BA/BS or master’s 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