Pharma QA Auditor — GMP Compliance & Inspections

Actalent

New York (NY)

On-site

USD 55,000 - 75,000

Full time

14 days+

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Job summary

Actalent is seeking a QA Auditor in New York to perform in-house line audits of pharmaceutical filling and packaging operations, ensuring compliance with SOPs and regulatory standards. This role reviews production activities and batch records for adherence to SOPs, overseeing material release and documentation control.

Onsite training is provided, and the position suits motivated individuals with strong interest in quality assurance and cGMP practices.

Qualifications

1–4 years of experience in Quality Assurance or Manufacturing, preferably in an FDA-regulated environment.
Associates degree in Science or equivalent is required.
Working knowledge of contemporary cGMP practices and procedures is preferred.
Knowledge of Good Documentation Practices.

Responsibilities

Perform in-house line audits of pharmaceutical filling and packaging operations to verify compliance with SOPs and quality standards.
Review manufacturing activities and documentation for adherence to SOPs and applicable regulations.
Conduct line clearances to ensure production lines are properly prepared and free of previous product and materials before new operations begin.
Perform in-process inspections to monitor product quality during manufacturing.
Conduct end-item inspections to confirm that finished products meet specifications and quality requirements.