GMP Quality & Compliance Specialist

Sharp Services; Macungie (Lehigh County); On-site; USD 68,000 - 95,000; Full time

Job summary

Sharp Services in Allentown, PA is seeking a Quality Specialist to provide quality oversight, GMP guidance, and decisions across designated areas within Sharp Commercial sites. You will collaborate with internal teams, support GMP initiatives, and ensure compliance with FDA regulations for Pharmaceutical operations.

The role covers Allentown, Macungie and/or Conshohocken, with emphasis on quality inspections, documentation, and continuous improvement through CAPA and data analysis.

Qualifications

• Bachelor’s degree preferred with 1–3 years related experience, or Associate’s Degree with 3–5 years of related experience.
• Experience in inspection of Pharmaceutical or related industry is required.
• Outside certification of quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired.

Responsibilities

• Actively participate in non-conformance investigations with root cause and CAPA planning.
• Review and approve quality documentation such as forms, work instructions, shipping requirements, specifications, etc.
• Complete 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.

Skills

Mathematical skills

Language skills

Written communication

Problem solving

Computer skills

Education

Bachelor’s degree preferred

Associate degree with 3–5 years

ASQ / CQIA / CQI / CQT / Lean Six Sigma certs

Tools

Microsoft Office Suite

Electronic QMS

Job description

Sharp Services in Allentown, PA is seeking a Quality Specialist to provide quality oversight, GMP guidance, and decisions across designated areas within Sharp Commercial sites. You will collaborate with internal teams, support GMP initiatives, and ensure compliance with FDA regulations for Pharmaceutical operations.

The role covers Allentown, Macungie and/or Conshohocken, with emphasis on quality inspections, documentation, and continuous improvement through CAPA and data analysis.