Evening QA Specialist - cGMP/NPI Lead

Pinnaql, Inc.

Juncos (PR)

On-site

USD 80,000 - 120,000

Full time

2 days ago

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Job summary

Validation & Engineering Group, Inc. is seeking a Specialist QA to support the quality assurance program within a pharmaceutical manufacturing environment. The role emphasizes cGMP compliance, approvals of validation documents, and participation in NPI and site audits.

The ideal candidate will bring leadership, strong communication, and bilingual English/Spanish capabilities to drive quality improvements and regulatory readiness across operations.

Qualifications

Doctorate or Masters with related experience.
Bachelor with 4 years related experience.
Experience in QA for pharmaceutical manufacturing and compliance.
Knowledge of cGMP, cGLP and regulatory expectations.

Responsibilities

Execute Quality disposition for bulk drug substances.
Provide QA oversight for API manufacturing, testing, storage, and handling per cGMP/cGLP.
Identify and document deviations and ensure proper CAPA.
Ensure production records and testing results are complete and compliant.
Collaborate across functions to support QMS processes and audits.

Skills

Strong organizational skills

Excellent communication skills

Bilingual in English and Spanish

Education

Doctorate

Masters + 2 years of related experience

Bachelors + 4 years of related experience

Tools

CDOCS

Maximo

TrackWise

LIMS

MES/eBRS

SAP

Job description

The ideal candidate will bring leadership, strong communication, and bilingual English/Spanish capabilities to drive quality improvements and regulatory readiness across operations.

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