Senior QA: Inspection, Labelling & Packaging Lead

Vector Talent; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Vector Talent is seeking a QA Senior Engineer to lead inspection, labeling and packaging quality systems for a global CDMO focused on parenteral injectable drugs.

The role involves supervising finished product inspection, labeling, packaging and serialization activities, ensuring compliance with FDA/EMA and related guidelines, and partnering with Manufacturing, Technical Services and QA teams to drive continuous improvement.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline or 10+ years in lieu of a degree.
• Minimum 5 years in pharmaceutical/biopharmaceutical QA with finished product inspection and packaging systems.
• 3+ years in GMP-regulated parenteral/sterile injectable environments.
• Knowledge of FDA (21 CFR Parts 210, 211), EU GMP Annex 1, ICH, USP <790> / <1790> guidance, and DSCSA.
• Experience with visual inspection methods and ISR defect classification.

Responsibilities

• Provide quality oversight for finished product visual inspection of vials, syringes and cartridges.
• Own quality systems for labelling, packaging and serialization ensuring regulatory compliance.
• Author and approve SOPs, work instructions, batch records, specifications.
• Lead deviation investigations, CAPA and root cause analyses.
• Collaborate to develop inspection parameters, AQL criteria and defect libraries.
• Maintain audit readiness for FDA/EMA/client audits.
• Oversee validation of inspection equipment and labeling systems.
• Review change controls, risk assessments and validation reports.
• Support QA floor escalations related to inspection activities.
• Stay updated on evolving regulatory expectations for parenteral products.

Skills

QA Oversight

GMP Knowledge

Serialization

Inspection

Labeling

CAPA

Audits

Documentation

Root Cause

Education

BS in Science

Tools

MS Office

Job description

Vector Talent is seeking a QA Senior Engineer to lead inspection, labeling and packaging quality systems for a global CDMO focused on parenteral injectable drugs.

The role involves supervising finished product inspection, labeling, packaging and serialization activities, ensuring compliance with FDA/EMA and related guidelines, and partnering with Manufacturing, Technical Services and QA teams to drive continuous improvement.