Quality Auditor

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 :

• Host customer audits.
• Write responses to customer audit observations.
• Support the supplier audit program, including auditing of suppliers and writing of supplier qualification, routine and for cause audit reports.
• Support site specific internal audit program, including performing and documenting internal audits.
• Review and evaluate 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.

SUPERVISORY RESPONSIBILITIES :

None

EDUCATION AND EXPERIENCE REQUIREMENTS :

• Bachelor's Degree and four to six years related experience in a pharmaceutical industry with a minimum of one year's experience conducting cGMP compliance audits, or comparable industry experience.
• 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.

GENERAL SKILLS :

• Excellent organizational, analytical, critical thinking, planning, problem solving and customer facing skills required.
• Above average written and oral communication skills required.

MATHEMATICAL SKILLS :

Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry.

LANGUAGE SKILLS :

• Ability to effectively present information to the following groups, both verbally and written :
• Internal : Frequent contact with all Sharp department employees for information exchange, collaboration, problem solving, direction regarding customer audit issues and cGMP issues.
• External : Frequent contact with customer representatives conducting audits and addressing technical issues. Occasional contact with regulatory agencies conducting inspections and addressing technical issues.
• Ability to read and interpret common scientific data. Ability to respond to common inquiries from customers, suppliers, or regulatory agencies.

Ability to direct and respond to inquiries from other Sharp employees.

REASONING ABILITY :

Ability to read and interpret customer agreements and regulatory guidelines. Ability to consider audit participants viewpoints relative to the company’s Quality System and the established requirements.

CERTIFICATES, LICENSES, REGISTRATIONS :

• Must be proficient in Microsoft Office Suite.
• Proficiency with Veeva Quality One or other electronic quality management system desired.
• ASQ Certified Quality Auditor certification preferred.

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 accommodations 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 accommodations 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.
30+ days ago