Contract Regulated QA Specialist | cGMP

ProQuality Network; Coffeyville (KS); Hybrid; USD 70,000 - 110,000; Full time

Job summary

ProQuality Network is seeking a Specialist QA (Regulated Industry) for a contract assignment to support our client’s Quality Assurance program, ensuring compliance with cGMP and internal quality systems with minimal supervision.

The role oversees manufacturing, validation, change management, investigations, audits, and site quality programs; reviews MPs, validation reports, CAPAs, and risk assessments, and acts as QA Manager designee on CCRB, ensuring release decisions are compliant.

Qualifications

• Master’s degree with 2 years related experience or higher.
• Bachelor’s degree with 4 years related experience.
• Associate degree with 8 years related experience.
• High School Diploma/GED with 10 years related experience.

Responsibilities

• Review and approve MPs and validation reports (including PPQ).
• Lead deviation investigations and root cause analyses.
• Own site quality program procedures and CCRB risk reviews.
• Perform lot disposition and authorize product release for shipment.
• Lead site audits and ensure QA/QAL processes are compliant.

Skills

Project management

Cross-functional leadership

Regulatory compliance

QA/QAL processes

Data analysis

Documentation review

Communication

Education

Master’s degree

Bachelor’s degree

Associate degree

High School Diploma/GED

Job description

ProQuality Network is seeking a Specialist QA (Regulated Industry) for a contract assignment to support our client’s Quality Assurance program, ensuring compliance with cGMP and internal quality systems with minimal supervision.

The role oversees manufacturing, validation, change management, investigations, audits, and site quality programs; reviews MPs, validation reports, CAPAs, and risk assessments, and acts as QA Manager designee on CCRB, ensuring release decisions are compliant.