QA Specialist 3469135

ProQuality Network; United States; Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Quality Assurance (QA) Specialist to support quality systems and regulatory compliance in a cGMP environment. This onsite role in the East Region, Puerto Rico, is contracted for approximately 9 months with 1 opening.

The candidate will oversee QA processes across manufacturing, validation, change control, and product release, ensuring strict documentation and regulatory alignment.

Qualifications

• Master’s degree with 2 years of directly related experience, or Bachelor’s with 4 years, or Associate’s with 8 years, or High School Diploma/GED with 10 years.
• Experience in GMP-regulated environment with manufacturing and process validation.
• Experience with New Product Introduction (NPI), Change Control, FATs, Validation, PPQs.
• Strong project management and cross‑functional leadership.

Responsibilities

• Review and approve Master Production Records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate as a Quality representative in incident triage teams.
• Approve Environmental Characterization reports and planned incidents.
• Support the release of sanitary utility systems.
• Represent Quality Assurance in NPI project teams.
• Lead investigations and participate in site audits.
• Act as designee for the QA Manager during local CCRB meetings.
• Review and assess Risk Assessments, Change Controls, and CAPA records.
• Review and approve Work Orders, EMS/BMS alarms, and NC investigations.

Skills

Project management

Cross-functional leadership

QA/QAL experience

GMP compliance

Documentation control

Regulatory liaison

Quality investigations

Education

Master’s degree w/ 2 years

Bachelor’s degree w/ 4 years

Associate’s degree w/ 8 years

High School Diploma/GED w/ 10 years

Tools

Microsoft Office

Database

Presentation tools

Job description

Quality Assurance (QA) Specialist (3469135)

Location: East Region, Puerto Rico (Open to Puerto Rico residents who are U.S. Citizens)

Work Arrangement: 100% Onsite | Administrative Shift

Contract Duration: Approximately 9 months

Available Positions: 1

Summary

Our client, a leading organization within the regulated biopharmaceutical industry, is seeking a Quality Assurance (QA) Specialist to support its quality systems and compliance programs under minimal supervision. The selected professional will perform QA oversight and approval functions related to manufacturing, validation, change control, and product release activities. This role requires a strong understanding of cGMP regulations, quality systems, and technical documentation to ensure operational excellence and regulatory compliance.

This opportunity is offered by contract through ProQuality Network.

Preferred Qualifications

• Experience in New Product Introduction (NPI), Change Control, Factory Acceptance Testing (FATs), Validation, and Process Performance Qualification (PPQs).
• Demonstrated experience supporting manufacturing and process validation activities within a GMP-regulated environment.

Key Responsibilities

• Review and approve Master Production Records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate as a Quality representative in incident triage teams.
• Approve Environmental Characterization reports and planned incidents.
• Support the release of sanitary utility systems.
• Represent Quality Assurance in NPI project teams.
• Lead investigations and participate in site audits.
• Serve as owner for site quality program procedures.
• Act as designee for the QA Manager during local CCRB meetings.
• Review and assess Risk Assessments, Change Controls, and CAPA records.
• Review and approve Work Orders, EMS/BMS alarms, and NC investigations.
• Support Automation, Facilities, and Environmental program activities.
• Provide lot disposition and authorize product lots for shipment.

Education Requirements

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

Core Competencies and Skills

• Strong project management and organizational skills; ability to follow assignments through completion.
• Proven ability to initiate and lead cross‑functional teams.
• Advanced skills in leadership, influence, and negotiation.
• In-depth knowledge of manufacturing, QA, QAL, validation, and process development operations.
• Experience interacting with regulatory agencies and understanding of GMP regulations.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), database, and presentation tools.
• Strong written and verbal communication, facilitation, and presentation skills.
• Ability to work independently and collaborate effectively at all organizational levels.
• Proficient in data trending, compliance evaluation, and quality risk assessments.
• Demonstrated alignment with corporate values and leadership principles.

Join Our Network

This is an excellent opportunity for a motivated Quality professional to contribute to a world‑class biopharmaceutical environment while advancing their expertise in quality systems and compliance oversight.