Quality Specialist - 3rd Shift (GMP & Compliance)

Sharp Services; Allentown (Lehigh County); On-site; USD 70,000 - 95,000; Full time

Job summary

Sharp Services is seeking a Quality Specialist to provide quality oversight and GMP guidance across designated areas within Sharp Commercial sites in Allentown. You will support quality operations, analyze data, train and coach teams, and interact with customers to ensure FDA compliance for pharmaceutical/packaging operations.

The role involves collaboration with internal teams, CAPA and non-conformance investigations, and timely documentation control to minimize risk and ensure product quality

Qualifications

• Bachelor’s degree preferred or equivalent with related experience.
• Experience in pharmaceutical/packaging quality.
• ASQ CQIA/CQI certification helpful.

Responsibilities

• Actively participate in non-conformance investigations with root cause analysis.
• Review and approve quality documents and specifications.
• Complete QMS actions for change controls, non-conformance, CAPAs and complaints.
• Support customer relationships related to quality and compliance.
• Identify risks and facilitate timely containment actions.
• Perform in-process inspections and ensure testing meets requirements.
• Audit shop floor and warehouse to ensure process compliance.

Skills

GMP knowledge

QA auditing

CAPA investigation

Statistical analysis

Documentation control

FDA regulations

Education

Bachelor's degree preferred

Tools

MS Office

Electronic QMS

Job description

Sharp Services is seeking a Quality Specialist to provide quality oversight and GMP guidance across designated areas within Sharp Commercial sites in Allentown. You will support quality operations, analyze data, train and coach teams, and interact with customers to ensure FDA compliance for pharmaceutical/packaging operations.

The role involves collaboration with internal teams, CAPA and non-conformance investigations, and timely documentation control to minimize risk and ensure product quality