QA Auditor

Sharp Services, LLC; Allentown, Northern (Lehigh County, KY); On-site; 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

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 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 that 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.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.