Quality Audit Specialist

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

At Sharp, being resourceful is a defining value, not just a buzzword. We adapt to changing circumstances; adjusting our plans when we need to. We think through how a project might play out so we can anticipate challenges while finding clever ways to solve problems.

We’re looking for resourceful, adaptable professionals who can navigate evolving circumstances.

The Quality Audit Specialist is responsible for supporting and maintaining the site's internal, supplier, and customer audit programs. The role coordinates and hosts customer audits, performs internal and supplier audits, tracks audit observations and corrective actions, and supports inspection readiness activities to ensure compliance with company procedures and applicable regulatory requirements.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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 applicable regulations, customer requirements, and company procedures.
• Review, communicate, and track audit observations, deviations, and compliance gaps to ensure timely implementation and closure of corrective actions.
• Support regulatory and agency inspections, audits, investigations and inquiries
• Responsible for maintenance of the approved/qualified supplier listings and service provider listings
• Prepare audit reports, document audit observations, and create and track CAPAs related to audit findings
• Identify audit trends, systemic issues, and opportunities for improvement, and partner with cross-functional teams to drive sustainable compliance and quality system enhancements.
• Identify recurring compliance risks and systemic issues through audit activities and support implementation of effective corrective and preventive measures to improve quality system performance.
• Performs special projects and/or assignments as indicated by Quality Management
• Support requests from internal and external customers as needed

Qualifications

• Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.
• Minimum 3 years relevant work experience in a cGMP environment
• Advanced knowledge of GMPs , Auditing and Quality Assurance/Quality Control skills and the ability to communicate this knowledge to the organization professionally and succinctly
• Quality Assurance experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
• Must be able to travel up to 25% (domestic).