QA Inspection Specialist – Qualification

QA Inspection Specialist – Qualification

Requirements

• Knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products
• Experience using and/or developing qualification kits and qualifying operators
• Experience in developing and implementing employee training programs
• Understanding of biologics manufacturing operations
• Ability to pass a visual acuity exam according to SOP requirements and gown for an ‘A’ classification
• Ability to learn and use computerized systems for daily performance of tasks
• Organized and have attention to detail
• Ability to prioritize multiple assignments and changing priorities

Responsibilities

• Responsible for qualification preparation, including documentation readiness, qualification/training kit readiness and scheduling for initial and annual requalification of visual inspectors and qualification kits
• Responsible for coordinating and reviewing progress of inspectors on evaluation assessments and qualification trials and conducting the evaluation of inspectors after qualification completion
• Provide formal instructions according to SOP/Protocol to a group of inspectors in a qualification setting
• Coordinate/supervise qualification room and ensures the environment for inspectors is efficient for qualification activities
• Oversee/monitor inspection methods and inspector adherence to protocol and procedures during qualification activities
• Maintains confidentiality and security of all qualification materials, logbooks, and other documentation as applicable
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of operations; where current documents are not adequate, identify path forward for establishment of procedures
• Develop, write, review, and approve SOPs, specifications, and other documents to support drug product operations
• Accountable for maintaining project timelines associated with initiatives to support the evolving business
• Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents (electronic and paper based)
• Performs On-the-floor Visual Inspection Observation of Inspectors technique
• Review and approval of documents including executed Batch Records and SOPs (electronic and paper-based)
• Complete daily operations per management mentorship in a multifaceted environment
• Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards
• Provide mentorship during on-the-floor manufacturing
• Support audits, inspections and investigations

Preferred Qualifications

No preferred qualifications provided.