Quality Specialist (3rd Shift) - GMP & Process Improvement

Sharp Corporation; Allentown (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Packaging Services is seeking a Quality Specialist to provide quality oversight, GMP guidance and support across designated functional areas at Allentown/Macungie/Conshohocken sites. You will collaborate with internal teams and may represent Quality in customer interactions.

You will design and implement GMP initiatives, drive continuous improvement through data analysis, training and coaching, and support regulatory audits and CAPA processes with cross-functional stakeholders.

Qualifications

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

Responsibilities

• Participate in non-conformance investigations with root cause analysis and CAPA planning.
• Review and approve quality documentation (forms, work instructions, SOPs).
• Support customer relationships related to Quality and participate in audits.

Skills

Quality Assurance

GMP Knowledge

CAPA

Root Cause Analysis

Data Analysis

Training

Regulatory Compliance

Education

Bachelor’s degree

ASQ/CQIA/Lean Six Sigma certification

Tools

Microsoft Office Suite

Electronic QMS

Job description

Sharp Packaging Services is seeking a Quality Specialist to provide quality oversight, GMP guidance and support across designated functional areas at Allentown/Macungie/Conshohocken sites. You will collaborate with internal teams and may represent Quality in customer interactions.

You will design and implement GMP initiatives, drive continuous improvement through data analysis, training and coaching, and support regulatory audits and CAPA processes with cross-functional stakeholders.