GMP Quality Specialist, Compliance & Continuous Improvement

Sharp Clinical Services; Macungie (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Clinical Services is seeking a Quality Specialist to provide quality oversight, GMP guidance and support within designated functional areas. You will work closely with internal teams and may represent Quality in customer interactions.

The role focuses on implementing GMP initiatives, data analysis, training, and continuous improvement in collaboration with internal and external stakeholders across Allentown, Macungie and Conshohocken. Strong QA background and certifications are preferred.

Qualifications

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

Responsibilities

• Actively participate in non-conformance investigations identifying root cause and CAPA.
• Review and approve quality documentation (forms, work instructions, shipping requirements, specifications).
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.

Skills

Statistical skills

Quality mindset

Problem solving

Communication

Decision making

Interpersonal skills

Education

Bachelor’s degree (preferred)

Associates degree with 3–5 years experience

Quality certification (ASQ, CQIA, CQI, CQT, Lean Six Sigma)

Tools

Microsoft Office

Electronic QMS

Job description

Sharp Clinical Services is seeking a Quality Specialist to provide quality oversight, GMP guidance and support within designated functional areas. You will work closely with internal teams and may represent Quality in customer interactions.

The role focuses on implementing GMP initiatives, data analysis, training, and continuous improvement in collaboration with internal and external stakeholders across Allentown, Macungie and Conshohocken. Strong QA background and certifications are preferred.