Specialist QA

QRC Group • Juncos, PR

2d

About The Position

We are seeking a Specialist QA with GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired.

Requirements

• Degree in a related field with applicable experience: Doctorate, Master's + 2 years of experience, Bachelor's + 4 years of experience, Associate's + 8 years of experience, High School Diploma/GED + 10 years of experience.
• Bilingual English and Spanish communication skills.
• Experience in Quality Assurance within a GMP-regulated environment.
• Experience reviewing and approving Change Controls, Deviations, CAPAs, Protocols, Reports, and SOPs.
• Experience supporting packaging and inspection operations.

Nice To Haves

• Strong knowledge of GDP
• Strong knowledge of electronic quality systems

Responsibilities

• Review and approval of change controls
• Review and approval of deviations
• Review and approval of CAPAs
• Review and approval of protocols
• Review and approval of reports
• Review and approval of procedures
• Support packaging/inspection operations
• Collaborate effectively with Manufacturing, Engineering, and Process Development

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed