Quality Assurance & Audit Specialist (GMP/Regulatory)

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 85,000 - 105,000; Full time

Job summary

Sharp Clinical Services is seeking a Quality Audit Specialist to support and manage internal, supplier, and customer audit programs. You will plan, conduct, and document audits, track observations and CAPAs, and assist with regulatory inspections to ensure compliance with GMP requirements.

The role requires a Bachelor’s or equivalent in science/technical fields, at least 3 years in a cGMP setting, and the ability to travel up to 25% domestically.

Qualifications

• Bachelor's or associate degree in science/technical field preferred.
• Minimum 3 years of experience in a cGMP environment.
• Advanced knowledge of GMPs, auditing and QA/QC.
• Ability to travel up to 25% (domestic).
• Strong communication and organizational skills.

Responsibilities

• Manage the Supplier and Internal Audit Program including preparation, scheduling and monitoring of audit activities.
• Ensure audit deliverables, responses, corrective action commitments, and associated documentation are completed accurately and within required timelines.
• Coordinate and host customer QA and qualification audits.
• Plan, conduct, and document internal and supplier audits to assess compliance with regulations and company procedures.
• Review, communicate, and track audit observations, deviations, and compliance gaps to ensure timely CAPA closure.
• Support regulatory inspections, audits, investigations and inquiries.
• Maintain the approved/qualified supplier and service provider listings.
• Prepare audit reports, document audit observations, and track CAPAs related to audit findings.
• Identify audit trends and systemic issues, driving quality system enhancements.

Skills

GMP knowledge

Auditing

Quality Assurance

Quality Control

Education

Science/Technical degree (Bachelor's or Associate)

Job description

Sharp Clinical Services is seeking a Quality Audit Specialist to support and manage internal, supplier, and customer audit programs. You will plan, conduct, and document audits, track observations and CAPAs, and assist with regulatory inspections to ensure compliance with GMP requirements.

The role requires a Bachelor’s or equivalent in science/technical fields, at least 3 years in a cGMP setting, and the ability to travel up to 25% domestically.