Onsite QA Specialist - Regulated QA (6-Month Contract)

ProQuality Network; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProQuality Network is seeking a Specialist QA to support our client’s quality assurance program within a highly regulated manufacturing environment. This is a contract opportunity onsite for approximately six months, focusing on validation, change control, investigations, NPI, and cross-functional collaboration in pharmaceutical or biotechnology operations.

The role will execute and lead QA activities with minimal supervision, ensuring compliance with FDA regulations and internal procedures,

Qualifications

• Master’s degree plus 2 years of directly related experience or
• Bachelor’s degree plus 4 years of directly related experience or
• Associate’s degree plus 8 years of directly related experience or
• High School Diploma/GED plus 10 years of directly related experience

Responsibilities

• Review and approve MPs (Manufacturing Procedures).
• Review and approve process validation protocols and reports (IQ/OQ/PQ/PPQ).
• Serve as QA representative on Incident Triage Teams.
• Review and approve Environmental Characterization Reports.
• Approve and release sanitary utility systems.
• Review and approve planned incidents, non-conformances, and CAPA records.
• Lead quality investigations with timely root cause analysis and corrective actions.
• Lead and support site audits and inspection readiness activities.
• Own and maintain site quality program procedures.
• Act as designee for QA Manager on the local CCRB.
• Review and approve risk assessments and change control documentation.
• Support automation, facilities, and environmental programs from QA oversight.
• Review and approve work orders and EMS/BMS alarms.
• Provide lot disposition decisions and authorize product release for shipment

Skills

Project management

Cross-functional teamwork

Stakeholder management

Data analysis & risk evaluation

Technical writing

MS Office

Education

Master's degree + 2 years related exp

Bachelor's degree + 4 years related exp

Associate's degree + 8 years related exp

High School Diploma/GED + 10 years related exp

Job description

ProQuality Network is seeking a Specialist QA to support our client’s quality assurance program within a highly regulated manufacturing environment. This is a contract opportunity onsite for approximately six months, focusing on validation, change control, investigations, NPI, and cross-functional collaboration in pharmaceutical or biotechnology operations.

The role will execute and lead QA activities with minimal supervision, ensuring compliance with FDA regulations and internal procedures,