Quality Specialist, 3rd Shift - GMP & CAPA Expert

Sharp Clinical Services; Allentown (Lehigh County); On-site; USD 90,000 - 120,000; Full time

Job summary

Sharp Clinical Services seeks a Quality Specialist to provide quality oversight across designated GMP areas at Sharp Commercial sites, including Allentown and surrounding locations. You will lead QA activities, drive CAPA, and support continuous improvement through data analysis and training.

In this role you will collaborate with operations, sales, and regulatory teams, ensure compliance with FDA regulations for pharmaceutical operations, and represent Quality in customer interactions when

Qualifications

• Bachelor’s degree required or equivalent experience with 1–3 years in QA in pharmaceutical/packaging environments.
• Experience in non-conformance investigations, CAPA, and change controls is desirable.
• Working knowledge of FDA regulations pertaining to Pharmaceutical/Pharmaceutical Packaging Operations.

Responsibilities

• Actively participate in non-conformance investigations with root-cause analysis and CAPA planning.
• Review and approve quality documentation (forms, work instructions, SOPs, etc.).
• Support customer relationships related to Quality and regulatory audits as needed.
• Identify and mitigate potential quality risks and ensure compliance of processes and product.
• Perform in-process inspections and participate in QA testing and inspections.

Skills

Quality Assurance

CAPA

Root Cause Analysis

Regulatory Knowledge

Data Analysis

Education

Bachelor's degree

Associate degree

Tools

MS Office

QMS (electronic)

Job description

Sharp Clinical Services seeks a Quality Specialist to provide quality oversight across designated GMP areas at Sharp Commercial sites, including Allentown and surrounding locations. You will lead QA activities, drive CAPA, and support continuous improvement through data analysis and training.

In this role you will collaborate with operations, sales, and regulatory teams, ensure compliance with FDA regulations for pharmaceutical operations, and represent Quality in customer interactions when