Senior QA Specialist - Quality & Compliance Leader

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

1-year contract

Job summary

BioPharma Consulting JAD Group is seeking a Sr Specialist, Quality Assurance to serve as a technical expert supporting quality systems, validation activities, and regulatory compliance in a regulated manufacturing environment.

You will review and approve MPs, validation protocols, environmental reports, and quality records, while leading investigations and cross-functional collaboration to maintain compliance.

Qualifications

• Review and approve product manufacturing procedures (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Approve Environmental Characterization reports.
• Approve planned incidents and ensure proper documentation.
• Release sanitary utility systems in accordance with quality requirements.
• Represent Quality on incident triage teams.
• Represent QA on New Product Introduction (NPI) teams.
• Serve as designee for the QA Manager on the local Change Control Review Board (CCRB).
• Collaborate with Manufacturing, Facilities, Utilities, Validation, and Process Development teams.
• Lead investigations and ensure timely closure of quality events.
• Own and maintain site quality program procedures.
• Perform advanced data trending, evaluation, and compliance assessments.
• Support audit readiness and interact effectively with regulatory agencies.

Responsibilities

• Review and approve MPs.
• Approve validation protocols and reports.
• Approve Environmental Characterization reports.
• Approve planned incidents with proper documentation.
• Release sanitary utility systems per quality requirements.
• Represent QA on incident triage and NPI teams.
• Lead investigations and close quality events.

Skills

QA Knowledge

Regulatory Compliance

Data Trending

Validation Protocols

Technical Writing

Communication Skills

Documentation Systems

Project Management

Cross-functional Leadership

Negotiation Skills

Independent Work

Education

PhD/Doctorate in related field

Master’s degree in related field

Bachelor’s degree in related field

Associate degree in related field

High School diploma or GED

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

BioPharma Consulting JAD Group is seeking a Sr Specialist, Quality Assurance to serve as a technical expert supporting quality systems, validation activities, and regulatory compliance in a regulated manufacturing environment.

You will review and approve MPs, validation protocols, environmental reports, and quality records, while leading investigations and cross-functional collaboration to maintain compliance.