Hybrid QA Specialist – Validation & Compliance

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

Job summary

ProQuality Network seeks a Specialist QA to support our client’s Quality Assurance program in a regulated manufacturing environment. The role requires strong regulatory knowledge, technical expertise, and cross-functional collaboration with minimal supervision in an admin-focused hybrid setting.

The ideal candidate has a scientific or engineering background, experience with IOQ/PQ, deviations, change control, and technical writing, and can manage QA tasks and maintenance-related activities while

Qualifications

• Advanced degrees or equivalent experience in sciences or engineering.
• Experience with validations and commissioning & qualification (C&Q) of manufacturing equipment and lab bench equipment.
• Technical writing skills and knowledge of Quality Systems (Deviations, Change Control).
• Maintenance experience (Preventive Maintenance, Work Orders, Job Plans).
• Ability to work independently and lead cross-functional teams.
• Strong data trending and evaluation skills.
• Experience interacting with regulatory agencies.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and site audits.
• Oversee the release of sanitary utility systems.
• Approve planned incidents.
• Review risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Quality professional

Validations & C&Q

IOQ/PQ testing

Technical writing

Change control

Maintenance coordination

Education

Doctorate

Master’s degree + 2 years of directly related experience

Bachelor’s degree + 4 years of directly related experience

Associate’s degree + 8 years of directly related experience

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

Job description

ProQuality Network seeks a Specialist QA to support our client’s Quality Assurance program in a regulated manufacturing environment. The role requires strong regulatory knowledge, technical expertise, and cross-functional collaboration with minimal supervision in an admin-focused hybrid setting.

The ideal candidate has a scientific or engineering background, experience with IOQ/PQ, deviations, change control, and technical writing, and can manage QA tasks and maintenance-related activities while