Senior Quality Audit Specialist

Sharp Services; Allentown (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Sharp Services is seeking a Senior Compliance Specialist to maintain and improve quality systems for regulatory compliance (FDA 21 CFR 210, 211, 820, 821) and global standards. The role leads customer, internal, and supplier audit activities as a subject matter expert within Quality.

You will coordinate audits, analyze quality data, and serve as SME in QA functions; train personnel and drive CAPAs. Strong communication and cross-functional collaboration are essential.

Qualifications

• Bachelor's or Associate degree in science or technical field or equivalent.
• 7+ years of relevant work in a cGMP environment.
• Advanced knowledge of GMPs, GDPs, GLPs; auditing and QA/QC skills.
• Ability to lead audit activities and compliance initiatives independently.
• Experience communicating knowledge professionally and succinctly.
• Experience with Microsoft Office applications and quality management systems.

Responsibilities

• Coordinate and execute customer audits, including preparation, hosting, facilitation, response development, and closure.
• Monitor trends and metrics of Quality Events, customer complaints, and CAPAs.
• Back-up Management Representative for customer, FDA, and other regulatory inspections.
• Develop, coordinate, and submit audit responses with corrective and preventive actions.
• Identify and lead projects to improve overall Operational quality.
• Troubleshoot and resolve Quality issues through cross-functional partnerships.
• Plan and manage internal and supplier audits per the audit schedule.

Skills

Audit leadership

Regulatory knowledge

Quality improvement

Cross-functional collaboration

Problem solving

Education

Bachelor's or Associate degree in science/technical field

Tools

Microsoft Office

Quality Management Systems

Job description

Health and science don’t stand still, and neither do we. We’re curious. And we treat every day as a chance to learn and innovate — as individuals and as an organization.

You’ll be a great fit with Sharp if you:

• Embrace innovation


• Volunteer new ideas


• Enjoy expanding your own skills and knowledge

The Senior Compliance Specialist maintains and continuously improves quality systems to ensure compliance with applicable FDA regulations (FDA 21CFR, 210, 211, 820 and 821), and other global regulatory standards. This role independently leads and manages customer, internal, and supplier audit activities, serving as a subject matter expert and process leader within the Quality organization.

Essential Duties And Responsibilities

• Responsible for site coordination and execution of customer audits, including audit preparation, hosting, facilitation, response development, and closure to ensure commitments and due dates are met.


• Monitors and provides trend analysis and metrics of Quality Events, customer complaints, and change controls


• Act as back-up Management Representative for customer, FDA, and/ or other regulatory inspections.


• Leads the development, coordination, and submission of audit responses (customer, internal, and supplier), including corrective and preventive action plans


• Identify, drive, mentor, and implement projects that improve overall Operational quality


• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships


• Plans, conducts, and independently manages internal audits and supplier audits in accordance with the established audit schedule, including reporting and follow-up of identified observations.


• Monitors, trends, and reports quality metrics related to audits and investigations, supplier complaints, and CAPAs related to audit actions.


• Actively supports and participates in site process improvement initiatives


• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems


• Serve as a technical subject matter expert (SME) in support of department functions


• Train personnel and internal customers on relevant business processes


• Other duties as assigned.

Qualifications

• Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.


• Minimum 7 years relevant work experience in a cGMP environment


• Advanced knowledge of GMPs, GDPs, GLPs, Auditing and Quality Assurance/Quality Control skills and the ability to communicate this knowledge to the organization professionally and succinctly


• Demonstrated ability to lead audit activities and compliance initiatives independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, strong attention to detail and excellent organizational skills.


• Experience with Microsoft Office applications and quality management systems


• The ability to make sound regulatory interpretation, employ logic, and implement decisions from within the QA organization


• Demonstrated ability for effective communication, teamwork, and problem solving skills


• 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.


• Has adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance