Quality Audit Specialist — CGMP Compliance & Audits

Sharp Services; Bethlehem (Northampton County); On-site; USD 70,000 - 90,000; Full time

Job summary

Sharp Services in Bethlehem, PA is seeking a Quality Audit Specialist to support and maintain internal, supplier, and customer audit programs. You will coordinate and host audits, track observations and CAPAs, and support inspection readiness to ensure regulatory compliance.

The ideal candidate has a bachelor’s or higher degree in a science/technical field, at least 3 years in a cGMP environment, and strong auditing/QA/QC knowledge. Domestic travel up to 25% is required.

Qualifications

• Minimum 3 years in a cGMP environment.
• Knowledge of GMPs and auditing; communicates findings clearly.
• Willingness to travel up to 25% (domestic).

Responsibilities

• Manage the Supplier and Internal Audit Program including preparation, scheduling and monitoring of audit activities.
• Ensure audit deliverables, responses, corrective action commitments, and documentation are completed accurately and on time.
• Coordinate and host customer QA and qualification audits.
• Plan, conduct, and document internal and supplier audits to assess compliance with regulations, customer requirements, and procedures.
• Review, communicate, and track audit observations, deviations, and compliance gaps to ensure timely closure of corrective actions.
• Support regulatory inspections, audits, investigations and inquiries.
• Maintain approved/qualified supplier and service provider listings.
• Prepare audit reports and CAPA tracking.
• Identify audit trends and drive improvements with cross-functional teams.
• Identify recurring compliance risks and implement corrective actions to improve quality system performance.
• Perform special projects as directed by Quality Management.
• Support requests from internal and external customers.

Skills

GMP knowledge

Auditing

Quality Assurance

Quality Control

Communication skills

Education

Science/Technical degree

Job description

Sharp Services in Bethlehem, PA is seeking a Quality Audit Specialist to support and maintain internal, supplier, and customer audit programs. You will coordinate and host audits, track observations and CAPAs, and support inspection readiness to ensure regulatory compliance.

The ideal candidate has a bachelor’s or higher degree in a science/technical field, at least 3 years in a cGMP environment, and strong auditing/QA/QC knowledge. Domestic travel up to 25% is required.