QA Specialist: Validation, CAPA & Compliance Lead

Pinnaql, Inc.; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc., a Pinnaql company, is seeking a Specialist QA to support quality assurance across GMP manufacturing environments in the United States.

You will review MPs, approve validation protocols, lead investigations, and drive CAPA, change controls, and deviations while coordinating with Manufacturing, Engineering, and Process Development. Bilingual English/Spanish preferred.

Qualifications

• GMP manufacturing knowledge is required.
• Experience reviewing and approving change controls, deviations, CAPAs, and protocols.
• Strong data trending, documentation, and record-keeping skills.
• Fluent English and Spanish communication preferred.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and drive CAPA closure.
• Own site quality program procedures and QA documentation.
• Collaborate with Manufacturing, Engineering, and Process Development.
• Provide lot disposition and authorize lots for shipment.

Skills

GMP knowledge

CAPA management

Change controls

Root cause analysis

Bilingual English/Spanish

Education

Doctorate or MS + 2 years experience

Bachelor's +4 years experience

Associate +8 years experience

High school/GED +10 years experience

Job description

Validation & Engineering Group, Inc., a Pinnaql company, is seeking a Specialist QA to support quality assurance across GMP manufacturing environments in the United States.

You will review MPs, approve validation protocols, lead investigations, and drive CAPA, change controls, and deviations while coordinating with Manufacturing, Engineering, and Process Development. Bilingual English/Spanish preferred.