GMP Quality Specialist — CAPA & Compliance Leader

Sharp Services, LLC; Allentown (Lehigh County); On-site; USD 70,000 - 110,000; Full time

Job summary

Sharp Services, LLC is seeking a Quality Specialist to provide GMP guidance and quality oversight across designated Sharp Commercial sites. You will support, design, and implement GMP initiatives through data analysis, training, and collaboration with internal and external stakeholders.

Responsibilities include leading non-conformance investigations, CAPA planning, and ensuring regulatory compliance with FDA requirements.

Qualifications

• Bachelor’s degree and/or ASQ certification preferred with 1–3 years of related pharmaceutical quality experience.
• Experience in inspection of Pharmaceutical or related industry is required.
• Outside certification of quality skills (ASQ, CQIA, CQI, CQT, Lean Six Sigma) is highly desired.

Responsibilities

• Participate in non-conformance investigations and develop robust root cause analyses.
• Review and approve quality documentation (forms, work instructions, shipping requirements, specs).
• Close out QMS actions related to change controls, non-conformance, complaints and CAPAs.
• Support customer relationships related to Quality as needed.
• Identify and facilitate resolution of potential risks.
• Assess need for non-conformance and propose containment actions with leadership.
• Implement process controls, improvements, testing and inspection methods.
• Ensure testing and inspection meet internal and external requirements.
• Audit internal processes on shop floor and in warehouse for compliance.
• Review room/equipment logs and Master Packaging Records for accuracy.
• Author/review/approve quality docs including SOPs and forms.
• Provide regulatory and customer audit support.

Skills

Quality oversight

GMP knowledge

CAPA

Root cause analysis

QMS

Regulatory alignment

Documentation review

Training & coaching

Education

Bachelor’s degree preferred

Associates degree with related experience

Tools

ASQ certifications

Quality management tools

Job description

Sharp Services, LLC is seeking a Quality Specialist to provide GMP guidance and quality oversight across designated Sharp Commercial sites. You will support, design, and implement GMP initiatives through data analysis, training, and collaboration with internal and external stakeholders.

Responsibilities include leading non-conformance investigations, CAPA planning, and ensuring regulatory compliance with FDA requirements.