SUMMARY:

Under the direction of the Audit Manager, the Quality Auditor has the responsibilities for hosting customer audits, conducting supplier audits, and conducting internal cGMP compliance audits for the company. This role encompasses the entire audit process including support in regulatory and third-party audits. The Auditor responsibilities encompass Sharp Packaging Services, LLC commercial US facilities (Allentown, Conshohocken, and Macungie).

The impact of decisions relating to customer interface, supplier interface and regulatory agency interface could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

The following is a list of minimum responsibilities related to the Q.A. Auditor position. Other duties may also be assigned.

• Host customer audits.
• Write responses to customer audit observations.
• Support the supplier audit program, including auditing suppliers and writing of supplier qualifications, routine and for cause audit reports.  
• Support 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 audit process.
• Remain current with FDA inspectional trends and current industry standards for cGMP compliance.
• Follow Sharp SOPs governing internal and supplier audit programs.  Follow ISO 13485, principles of cGMPs and industry guidance documents.
• Assist in appropriate problem-solving initiatives to address customer or regulatory cGMP issues as requested by management.
• Other duties may be assigned as appropriate.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

None

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

• A minimum of one year of experience conducting cGMP compliance audits or comparable industry experience preferred.
• Knowledge of FDA cGMPs regulation required specifically 21 CFR 210/211, 820, Part 4
• Knowledge of ISO 13485 required
• Knowledge of ICH08, 09 and 10 desired.
• Knowledge of DEA regulations, ISO 9001 and ISO 15378 desired.
• Above average written and oral communication skills required.
• Above average organization and planning skills required.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently is required to sit.  The employee is occasionally required to stand, walk, and reach with hands and arms.  The employee must occasionally lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor.  The working environment is clean and not normally subject to hazardous environment or conditions.

Approximately 30 percent travel between sites.  Approximately 15 percent travel to supplier sites is required.  A valid driver’s license is required.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.