JT711 - SR. SPECIALIST QA

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

Job summary

Quality Consulting Group, LLC seeks a motivated QA professional to join our team in Puerto Rico & USA. You will approve validation protocols, participate in incident triage, and lead QA investigations to sustain world-class manufacturing standards.

The role demands a bachelor's degree with 6 years of related experience, expertise in commissioning, qualification, and computer validation, and strong risk management and documentation practices to ensure regulatory compliance.

Qualifications

• Bachelor's degree and 6 years of directly related experience.
• Facilities and Utilities Commissioning and Qualification.
• Computer System Validation.
• Equipment validation.
• Risk Assessments.
• Good Documentation Practices, Data Integrity.
• Change Controls.
• Standard Operating Procedure development.
• Syringe/Vials inspection process.
• Documents revision and approval.
• Strong knowledge in decision making techniques.
• Risk management related to quality standards and regulatory requirements.

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, validation, and process development.

Skills

Quality Assurance

Process validation

Risk assessment

Documentation

Education

Bachelor's degree plus 6 years experience

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Approve process validation protocols and reports for mfg. 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 and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.

Qualifications:

• Bachelor's degree and 6 yearsof directly related experience
• Facilities and Utilities Commissioning and Qualification,
• Computer System Validation,
• Equipment validation,
• Risk Assessments,
• KNEAT,CDOCS, SCADA, TRACKWISE,MAXIMO
• Good Documentation Practices, Data Integrity
• Change Controls,
• Standard Operation Procedure
• Syringe/Vials Inspection Process
• Documents revision and approval
• o Strong knowledge in Decision Making Techniques
• o Risk Management applicable procedures, quality standards, and regulatory requirements.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.