QA Specialist 35563

ProQuality Network; Juncos (PR); Hybrid; USD 70,000 - 110,000; Full time

Job summary

ProQuality Network seeks a Specialist Quality Assurance (QA) to support GMP compliance in a regulated biopharmaceutical manufacturing environment in Juncos, PR. The role emphasizes investigations, validation, environmental monitoring, and cross-functional collaboration.

The candidate will lead deviation investigations, support regulatory inspections, and ensure quality systems and procedures are followed, with a focus on product release and risk management.

Qualifications

• More than 10 years in the biopharmaceutical industry with at least 5 years QA experience.
• Regulatory inspections and audit readiness experience.
• Process validation and equipment qualification experience.
• Deviation investigations and quality approvals.

Responsibilities

• Review and approve manufacturing procedures and product master documents.
• Review and approve process validation protocols and validation reports.
• Lead deviation investigations and drive timely resolution.
• Lead internal quality audits and support regulatory inspection readiness.
• Represent QA on New Product Introduction (NPI) teams.
• Review and approve change control documentation and risk assessments.

Skills

Project management

Cross-functional leadership

Quality Assurance

Regulatory compliance

Investigations

Education

Master's +2 years

Bachelor's +4 years

Associate +8 years

HS Diploma +10 years

Job description

Title: Specialist Quality Assurance (QA) – Pharmaceutical Industry

Location: Juncos, Puerto Rico (Open only to Puerto Rico residents)

Schedule: Administrative shift with flexibility to support other shifts based on business needs.

Contract Duration: 7 months

Position Summary

Our client is seeking an experienced Specialist Quality Assurance (QA) to support quality and compliance activities within a regulated biopharmaceutical manufacturing environment. The selected candidate will work with minimal supervision to ensure compliance with current GMP regulations, internal quality standards, and regulatory requirements while supporting manufacturing, validation, environmental monitoring, and quality systems.

This position requires a strong background in Quality Assurance, regulatory compliance, investigations, validation, and cross-functional collaboration.

Preferred Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, Physics, Computer Science, or another scientific discipline is preferred.
• More than 10 years of experience in the biopharmaceutical industry, including at least 5 years of Quality Assurance experience.
• Demonstrated experience in:
• Quality Assurance and Quality Compliance
• Regulatory inspections and audit readiness
• Process validation and equipment qualification
• Process characterization
• Automation validation documentation and report review
• Deviation investigations and quality approvals
• Critical Utilities
• Environmental Monitoring trending and report approval

Key Responsibilities

• Review and approve manufacturing procedures and product master documents.
• Review and approve process validation protocols and validation reports.
• Participate in Quality Incident Triage activities.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent the Quality Assurance organization on New Product Introduction (NPI) teams.
• Lead deviation investigations and drive timely resolution.
• Lead internal quality audits and support regulatory inspection readiness.
• Develop, maintain, and improve site Quality Program procedures.
• Serve as the Quality Assurance Manager's designee on the local Change Control Review Board (CCRB), as required.
• Review and approve risk assessments.
• Provide Quality support for automation-related initiatives.
• Support facilities, utilities, and environmental compliance programs.
• Review and approve work orders.
• Review and approve EMS/BMS alarm assessments.
• Review and approve nonconformance investigations and CAPA records.
• Review and approve change control documentation.
• Perform final lot disposition and authorize product release for distribution.

Education

Candidates must meet one of the following education and experience combinations:

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

Required Skills and Competencies

• Strong project management and organizational skills.
• Ability to manage multiple priorities and complete assignments independently.
• Experience leading cross-functional teams and driving collaboration.
• Excellent leadership, influencing, and negotiation skills.
• Strong technical knowledge of Quality Assurance, validation, manufacturing processes, process development, and distribution operations.
• Experience interacting with regulatory agencies during inspections and compliance activities.
• Ability to identify, assess, and resolve compliance issues using a risk-based approach.
• Advanced experience with data analysis, trending, and evaluation.
• Strong written and verbal communication, presentation, and facilitation skills.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and database management tools.
• Ability to build effective working relationships across all organizational levels.
• Demonstrated commitment to quality, continuous improvement, and regulatory compliance.