Quality Auditor — cGMP, Supplier & Customer Audits

Sharp Services, LLC; Allentown (Lehigh County); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Sharp Packaging Services, LLC seeks a Quality Auditor to lead customer, supplier, and internal cGMP audits across US facilities (Allentown, Conshohocken, Macungie). You will host audits, respond to observations, and coordinate CAPAs with a focus on regulatory readiness and improvement opportunities.

The role requires knowledge of FDA cGMPs and ISO 13485, with strong communication and planning skills. Travel to sites will be required.

Qualifications

• Minimum of one year auditing for cGMP compliance or related experience.
• Knowledge of FDA cGMPs: 21 CFR 210/211, 820, Part 4.
• ISO 13485 knowledge is required.
• Knowledge of ICH guidelines (08/09/10) desired.
• Knowledge of DEA regulations, ISO 9001 and ISO 15378 desired.
• Strong written and verbal communication skills.
• Strong organization and planning skills.

Responsibilities

• Host customer audits.
• Write responses to customer audit observations.
• Support supplier audit program and write supplier qualifications and audit reports.
• Support site internal audit program and document internal audits.
• Review audit responses for CAPA effectiveness and close-out.
• Participate in regulatory agency inspections.
• Coordinate CAPA process for audits and inspections.
• Identify areas for continuous improvement in the audit process.
• Stay current with FDA inspection trends and cGMP guidance.
• Follow Sharp SOPs and ISO 13485 principles.

Skills

Audit management

cGMP

FDA regulatory

CAPA

Documentation

Regulatory inspections

Continuous improvement

Education

Bachelor's in Life Sciences

Tools

ISO 13485

Job description

Sharp Packaging Services, LLC seeks a Quality Auditor to lead customer, supplier, and internal cGMP audits across US facilities (Allentown, Conshohocken, Macungie). You will host audits, respond to observations, and coordinate CAPAs with a focus on regulatory readiness and improvement opportunities.

The role requires knowledge of FDA cGMPs and ISO 13485, with strong communication and planning skills. Travel to sites will be required.