Specialist QA #3429808

ProQuality Network; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProQuality Network is seeking a Senior QA Specialist to uphold regulatory standards and ensure patient safety across manufacturing and distribution processes. The role requires leading cross-functional teams and driving continuous improvement in quality systems.

Responsibilities include reviewing MP records, approving validation protocols, supporting incident triage, and owning site quality procedures. Strong project management and collaboration with regulatory bodies are essential.

Qualifications

• Advanced leadership, influencing, and negotiation abilities.
• Strong project management and organizational skills.
• Proven experience leading cross-functional teams.
• In-depth knowledge of manufacturing, distribution, quality assurance, validation, and process development.

Responsibilities

• Review and approve product Master Production Records (MPs).
• Approve validation protocols and reports for manufacturing processes.
• Participate in incident triage teams and request Quality support as needed.
• Oversee and release sanitary utility systems.
• Approve planned incidents and deviations.
• Represent QA in New Product Introduction (NPI) teams.
• Lead quality investigations and support resolution of issues.
• Lead and support site audits.
• Own and maintain site quality program procedures.
• Serve as designee for QA Manager in local Change Control Review Board (CCRB).
• Review and approve risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve Non-Conformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize product release for shipment.

Skills

Quality Assurance

Leadership

Cross-functional leadership

Documentation

Regulatory compliance

Education

Doctorate

Master’s degree with 2 years of directly related experience

Bachelor’s degree with 4 years of directly related experience

Associate’s degree with 8 years of directly related experience

High school diploma/GED with 10 years of directly related experience

Job description

Position: 1

Shift: 100% Onsite, Administrative Shift

Summary

The Specialist QA will perform a wide range of responsibilities in support of our client’s Quality Assurance program with minimal supervision. This role ensures compliance with regulatory standards, internal policies, and quality systems to maintain product integrity and patient safety.

Preferred Qualifications

• Educational background in Life Sciences or Engineering.
• Experience in New Product Introduction (NPI), Change Control, Factory Acceptance Tests (FATs), Validation, and Process Performance Qualification (PPQ).

Key Responsibilities

• Review and approve product Master Production Records (MPs).
• Approve validation protocols and reports for manufacturing processes.
• Participate in incident triage teams and request Quality support as needed.
• Oversee and release sanitary utility systems.
• Approve planned incidents and deviations.
• Represent QA in New Product Introduction (NPI) teams.
• Lead quality investigations and support resolution of issues.
• Lead and support site audits.
• Own and maintain site quality program procedures.
• Serve as designee for QA Manager in local Change Control Review Board (CCRB).
• Review and approve risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve Non-Conformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize product release for shipment.

Education Requirements

• Doctorate; OR
• Master’s degree with 2 years of directly related experience; OR
• Bachelor’s degree with 4 years of directly related experience; OR
• Associate’s degree with 8 years of directly related experience; OR
• High school diploma/GED with 10 years of directly related experience.
• Strong project management and organizational skills, with ability to drive assignments to completion.
• Proven experience leading cross-functional teams.
• Advanced leadership, influencing, and negotiation abilities.
• In-depth knowledge of manufacturing and distribution processes, quality assurance, validation, and process development.
• Ability to collaborate effectively with internal and external stakeholders, including regulatory agencies.
• Proficiency in word processing, presentations, databases, and spreadsheets.
• Strong written and oral communication, facilitation, and presentation skills.
• Ability to work independently and interact effectively at all organizational levels.
• Advanced data trending, evaluation, and compliance issue assessment.