Specialist Quality Assurance

We are seeking a highly skilled Quality Assurance Specialist to support the site’s Quality Assurance (QA) program. In this role, you will work under minimal supervision to ensure compliance with regulatory requirements, corporate standards, and Good Manufacturing Practices (GMP). You will provide quality oversight for manufacturing operations, validation activities, and quality systems, serving as a subject matter expert across multiple functional areas.

Key Responsibilities

• Review and approve Master Production Records (MPs), work orders, and other controlled documents.
• Approve process validation protocols and reports for manufacturing processes.
• Serve as QA representative on incident triage teams and New Product Introduction (NPI) projects.
• Review and approve Environmental Characterization reports and release sanitary utility systems.
• Lead investigations, audits, and maintain site quality program procedures.
• Review and approve risk assessments, nonconformance (NC) investigations, CAPA records, and change controls.
• Support automation, facilities, environmental programs, and respond to EMS/BMS alarms.
• Provide lot disposition and authorize product release for shipment.

Education & Experience Requirements

• Doctorate degree; OR
• Master’s degree with 3 years of directly related experience; OR
• Bachelor’s degree with 5 years of directly related experience; OR
• Associate’s degree with 10 years of directly related experience; OR
• High school diploma / GED with 12 years of directly related experience.

Preferred Qualifications

• Plant Quality Assurance experience in reviewing work orders, batch records, and on-the-floor documentation.
• Bulk Plant (Drug Substance) manufacturing experience.
• Proficiency in deviation management, GMP audits, and preparation of reports, protocols, validations, and periodic reviews.
• Experience conducting manufacturing area walkdowns, including critical utilities and classified areas.
• Prior roles as Quality Auditor or Quality Specialist in a GMP-regulated environment.

Skills & Competencies

• Strong project management and organizational skills with ability to drive assignments to completion.
• Ability to lead, influence, and negotiate across cross-functional teams.
• Deep knowledge of QA processes, manufacturing, validation, and distribution in a regulated environment.
• Demonstrated ability to interface with regulatory agencies.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and database systems.
• Strong communication skills (written, verbal, and presentation).