Sharp Services · 1 week ago
Quality Assurance Auditor
Allentown, PA
Full-time
Onsite
Entry Level
1+ years expSharp Services is a company focused on maintaining high standards in quality assurance. The Quality Assurance Auditor will host customer audits, conduct supplier audits, and perform internal cGMP compliance audits to ensure regulatory standards are met and risks are minimized.
Health CareLife Science
Responsibilities
Host customer audits
Write responses to customer audit observations
Support the supplier audit program, including auditing suppliers and writing of supplier qualifications, routine and for cause audit reports
Support site specific internal audit program, including performing and documenting internal audits
Review and evaluate the appropriateness of supplier and internal audit responses to ensure effective CAPAs and effectiveness checks are in place
Participate in regulatory agency inspections
Coordinate the Root Cause and Corrective Action / Preventative Action (CAPA) process as it relates to all audits and inspections
Identify areas for continuous improvement as part of audit process
Remain current with FDA inspectional trends and current industry standards for cGMP compliance
Follow Sharp SOPs governing internal and supplier audit programs. Follow ISO 13485, principles of cGMPs and industry guidance documents
Assist in appropriate problem-solving initiatives to address customer or regulatory cGMP issues as requested by management
Other duties may be assigned as appropriate
Qualification
Required
Knowledge of FDA cGMPs regulation required specifically 21 CFR 210/211, 820, Part 4
Knowledge of ISO 13485 required
Above average written and oral communication skills required
Above average organization and planning skills required
Preferred
A minimum of one year of experience conducting cGMP compliance audits or comparable industry experience preferred
Knowledge of ICH08, 09 and 10 desired
Knowledge of DEA regulations, ISO 9001 and ISO 15378 desired
Company
Sharp Services
Sharp Services provides contract packaging services for Rx, biotechnology, OTC/nutritional, clinical packaging, animal health.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$712.5M2022-01-20Debt Financing· $712.5M
2008-07-16Acquired
Leadership Team
Kevin Orfan
Chief Executive Officer
Brendan McAtamney
Chair
Recent News
2025-11-01
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