Quality Audit Specialist

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

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 requirementsEssential 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 activitiesEnsure audit deliverables, responses, corrective action commitments, and associated documentation are completed accurately and within required timelines.Coordinate and host customer QA and qualification auditsPlan, 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 inquiriesResponsible for maintenance of the approved/qualified supplier listings and service provider listingsPrepare audit reports, document audit observations, and create and track CAPAs related to audit findingsIdentify 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 ManagementSupport requests from internal and external customers as neededQualificationsBachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.Minimum 3 years relevant work experience in a cGMP environmentAdvanced knowledge of GMPs , Auditing and Quality Assurance/Quality Control skills and the ability to communicate this knowledge to the organization professionally and succinctlyQuality 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).