Regulated QA Specialist - 8-Month Contract

ProQuality Network; Northern (KY); Hybrid; USD 55,000 - 96,000; Full time

Job summary

ProQuality Network seeks a Specialist QA (Regulated Industry) for an 8-month project consultancy to support our client’s Quality Assurance program. The role involves working with aseptic processes, NPI, validation activities, change control, FATs, and PPQs under cGMP standards.

The candidate will act as QA Manager designee on the CCRB, lead deviation investigations, participate in site audits, and maintain site quality procedures while ensuring regulatory compliance.

Qualifications

• Master’s degree with related experience or
• Bachelor’s degree with related experience or
• Associate degree with related experience or
• High School Diploma with related experience

Responsibilities

• Review and approve Product Master Plans (MPs).
• Review and approve process validation protocols and reports, including PPQ activities.
• Serve as QA representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Authorize release of sanitary utility systems.
• Review and approve planned incidents.
• Lead deviation investigations with root cause analysis and CAPA development.
• Lead and participate in site audits.
• Own and maintain site quality program procedures.
• Act as QA Manager designee on the CCRB.
• Review and approve risk assessments.
• Support automation activities, including FATs and validation execution.
• Support facilities and environmental monitoring programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Review and approve NC investigations and CAPA records.
• Review and approve change control records.
• Perform lot disposition and authorize product release for shipment.

Skills

Project management

Organizational skills

Cross-functional leadership

Regulatory experience

Data analysis

Communication skills

Independent work

Education

Master's degree

Bachelor's degree

Associate degree

High School Diploma/GED

Tools

Database systems

Validation software

Job description

ProQuality Network seeks a Specialist QA (Regulated Industry) for an 8-month project consultancy to support our client’s Quality Assurance program. The role involves working with aseptic processes, NPI, validation activities, change control, FATs, and PPQs under cGMP standards.

The candidate will act as QA Manager designee on the CCRB, lead deviation investigations, participate in site audits, and maintain site quality procedures while ensuring regulatory compliance.