Senior QA Specialist: Process Validation & Compliance Lead

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented, highly motivated QA professional to join our team in Puerto Rico & USA. In this role, you’ll approve process validation protocols, lead investigations, and own program procedures, representing QA on cross-functional teams and CCRB.

You will manage commissioning/qualification activities, environmental characterization, and the release of sanitary utility systems, while collaborating with regulators and internal stakeholders to ensure compliance

Qualifications

• Bachelor's degree in related area required.
• 6 years of directly related experience required.
• Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOPs.
• Project management skills essential.
• Strong organizational skills with ability to follow assignments through to completion.
• Strong knowledge of manufacturing and distribution QA, QAL, validation and processes development.
• Demonstrated ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet skills.
• Excellent written and oral communication, facilitation and presentation skills.

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.

Skills

6 years of directly related experience

Project management

Strong communication

Strong organizational skills

Data trending and evaluation

Regulatory interactions

QA, QAL, validation processes

Education

Bachelor's degree in related area

Tools

Kneat

Good Documentation Practices

Change Controls

SOPs

QRAES

Job description

Quality Consulting Group, LLC is seeking a talented, highly motivated QA professional to join our team in Puerto Rico & USA. In this role, you’ll approve process validation protocols, lead investigations, and own program procedures, representing QA on cross-functional teams and CCRB.

You will manage commissioning/qualification activities, environmental characterization, and the release of sanitary utility systems, while collaborating with regulators and internal stakeholders to ensure compliance