Senior QA Specialist – Validation & Compliance Leader

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and across the USA is seeking a talented QA professional to join our team. You will contribute to a world-class manufacturing operation by approving validation protocols and reports, leading investigations, and representing QA on incident triage and NPI teams.

The ideal candidate holds a Bachelor's degree with 6 years of directly related experience, with strong CSV, GDP, risk management, and change control knowledge, plus hands-on experience with Q&As

Qualifications

• Bachelor's degree required with at least 6 years of related experience.
• Experience with Facilities and Utilities Commissioning and Qualification (C&Q).
• Knowledge of Computer System Validation (CSV).
• Experience with Equipment Validation.
• Experience with risk-based methodologies and risk assessments.
• Proficient with GDP and data integrity principles.
• Experience with Change Control processes.
• Experience developing and updating SOPs.
• Experience with Syringe and Vial Inspection Processes.
• Experience with Document Revision and Approval processes.
• Knowledge of Decision-Making Techniques and Risk Management.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Project management skills.
• Strong knowledge of manufacturing, QA, QAL, validation, and processes development.

Skills

QA expertise

Process validation

Risk assessment

Data integrity

Decision making

Education

Bachelor's degree + 6 years experience

Tools

KNEAT

C-DOCS

SCADA

TrackWise

Maximo

Job description

Quality Consulting Group, LLC in Puerto Rico and across the USA is seeking a talented QA professional to join our team. You will contribute to a world-class manufacturing operation by approving validation protocols and reports, leading investigations, and representing QA on incident triage and NPI teams.

The ideal candidate holds a Bachelor's degree with 6 years of directly related experience, with strong CSV, GDP, risk management, and change control knowledge, plus hands-on experience with Q&As