QA Auditor

About the role

The Quality Auditor is responsible for hosting customer audits, conducting supplier audits, and performing internal cGMP compliance audits across Sharp Packaging Services, LLC commercial US facilities (Allentown, Conshohocken, and Macungie). This role supports regulatory and third-party audits and involves significant interaction with customers, suppliers, and regulatory agencies, where decisions may expose the company to substantial risk or economic loss.

Responsibilities

• Host customer audits and write responses to customer audit observations.
• Support the supplier audit program, including auditing suppliers and writing supplier qualifications, routine, and for-cause audit reports.
• Support the site-specific internal audit program, including performing and documenting internal audits.
• Review and evaluate the appropriateness of supplier and internal audit responses to ensure effective CAPAs and effectiveness checks are in place.
• Participate in regulatory agency inspections.
• Coordinate the Root Cause and Corrective Action / Preventative Action (CAPA) process as it relates to all audits and inspections.
• Identify areas for continuous improvement as part of the audit process.
• Remain current with FDA inspectional trends and industry standards for cGMP compliance.
• Follow Sharp SOPs governing internal and supplier audit programs.
• Adhere to ISO 13485, principles of cGMPs, and industry guidance documents.
• Assist in problem-solving initiatives to address customer or regulatory cGMP issues as requested by management.
• Perform other duties as assigned.

Requirements

• Minimum of one year of experience conducting cGMP compliance audits or comparable industry experience (preferred).
• Knowledge of FDA cGMP regulations, specifically 21 CFR 210/211, 820, and Part 4.
• Knowledge of ISO 13485 (required).
• Knowledge of ICH Q8, Q9, and Q10 (desired).
• Knowledge of DEA regulations, ISO 9001, and ISO 15378 (desired).
• Above-average written and oral communication skills.
• Above-average organization and planning skills.

Physical Demands

• Frequently required to sit.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occasionally lift and/or move up to 10 pounds.
• Requires close vision, distance vision, and ability to adjust focus.

Work Environment

• Primarily office-based with periodic visits to the shop floor.
• Clean working environment, not normally subject to hazardous conditions.
• Approximately 30% travel between sites (Allentown, Conshohocken, Macungie).
• Approximately 15% travel to supplier sites.
• A valid driver’s license is required.