Specialist QA 3539244

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

Title: Specialist QA (3539244) – Regulated Industry

Work Schedule: 100% Onsite – Administrative Shift

Duration: Approximately 6 Months

Positions Available: 1

Position 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 supporting critical QA operations onsite.

The selected professional will execute and lead quality assurance activities under minimal supervision, ensuring compliance with FDA regulations, global quality standards, and internal procedures. The role requires strong experience in validation, change management, investigations, NPI, and cross-functional collaboration within pharmaceutical or biotechnology operations.

Preferred Qualifications

• Education in Life Sciences, Engineering, or a related technical discipline
• Experience with NPI, Change Control, FATs, Validation, and PPQ activities
• Background in FDA-regulated pharmaceutical or biotechnology environments

Key Responsibilities

• Review and approve Manufacturing Procedures (MPs).
• Review and approve process validation protocols and reports for manufacturing processes (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, ensuring 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 Change Control Review Board (CCRB).
• Review and approve risk assessments and change control documentation.
• Support automation, facilities, and environmental programs from a QA oversight perspective.
• Review and approve work orders and EMS/BMS alarms.
• Provide lot disposition decisions and authorize product release for shipment.

Education Requirements

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

Core Competencies & Skills

• Strong project management and organizational skills, with the ability to drive assignments to completion
• Demonstrated ability to initiate and lead cross-functional teams
• Advanced skills in influencing, negotiation, and stakeholder management
• Strong knowledge of manufacturing processes, QA/QAL systems, validation, and process development
• Experience interacting with regulatory agencies and supporting inspections
• Advanced data trending, analysis, and risk evaluation capabilities
• Strong technical writing and documentation review skills
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and database systems
• Strong written and verbal communication skills
• Ability to work independently while collaborating effectively across multiple organizational levels
• Ability to assess and resolve complex compliance issues