QA Specialist (Regulatory Industy) 3541064

ProQuality Network; United States; Presencial; USD 55.000 - 96.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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

Responsabilidades

• 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.

Conocimientos

Project management

Organizational skills

Cross-functional leadership

Regulatory experience

Data analysis

Communication skills

Independent work

Educación

Master's degree

Bachelor's degree

Associate degree

High School Diploma/GED

Herramientas

Database systems

Validation software

Descripción del empleo

QA Specialist (Regulatory Industy) 3541064

Title: Specialist QA (Regulated Industry) – 3541050

Duration: Approximately 8 Months

Positions Available: 1

SUMMARY

ProQuality Network is seeking a Specialist QA (Regulated Industry) for an 8-month project consultant assignment supporting our client’s Quality Assurance program. This role requires working under minimal supervision to provide quality oversight in a regulated manufacturing environment.

The selected candidate will support aseptic processes, New Product Introduction (NPI), validation activities, change control, FATs, and PPQs while ensuring compliance with cGMP standards and regulatory expectations.

KEY RESPONSIBILITIES

• Review and approve Product Master Plans (MPs).
• Review and approve process validation protocols and reports, including PPQ activities.
• Serve as Quality 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, including 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 local Change Control Review Board (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 Nonconformance (NC) investigations and CAPA records.
• Review and approve change control records.
• Perform lot disposition and authorize product release for shipment.

EDUCATION & EXPERIENCE REQUIREMENTS

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

Preferred Qualifications:

• Experience in aseptic manufacturing environments
• Experience with NPI, Change Control, FATs, Validation, and PPQ
• Experience in regulated pharmaceutical or biotechnology industries

REQUIRED COMPETENCIES & SKILLS

• Strong project management skills with the ability to meet deadlines.
• Excellent organizational skills and ability to follow assignments through to completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• In-depth knowledge of manufacturing, QA/QAL, validation, and process development.
• Experience interacting with regulatory agencies.
• Advanced data trending, analysis, and compliance evaluation skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and database systems.
• Strong written and verbal communication, facilitation, and presentation skills.
• Ability to work independently while effectively collaborating across multiple organizational levels.
• Demonstrated alignment with professional leadership practices and company values.