Pharma Quality Specialist - First Shift

Sharp Packaging Solutions, part of UDG Healthcare plc; Macungie (Lehigh County); On-site; USD 70,000 - 100,000; Full time

Job summary

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking a Quality Specialist to provide quality oversight and GMP guidance for designated functional areas at Sharp Commercial sites. You will support, design and implement GMP initiatives and continuous improvement within Quality Operations, using data analysis, training, and collaboration with internal and external stakeholders.

The role requires working knowledge of FDA regulations related to Pharmaceutical/Pharmaceutical Packaging

Qualifications

• Bachelor’s degree preferred with 1–3 years related experience or Associate with 3–5 years of related 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 with root-cause and CAPA planning.
• Review and approve quality documents such as forms, work instructions, and specifications.
• 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 with operations leadership.
• Audit internal processes on the shop floor and warehouse for compliance.

Skills

Root Cause Analysis

CAPA

QMS

Regulatory Compliance

Data Analysis

Training

Quality Documentation

Audits

Communication

Education

Bachelor's degree preferred

Associate degree + 3–5 years experience

ASQ CQIA/CQI/CQT certifications

Tools

Microsoft Office

Electronic QMS

Job description

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking a Quality Specialist to provide quality oversight and GMP guidance for designated functional areas at Sharp Commercial sites. You will support, design and implement GMP initiatives and continuous improvement within Quality Operations, using data analysis, training, and collaboration with internal and external stakeholders.

The role requires working knowledge of FDA regulations related to Pharmaceutical/Pharmaceutical Packaging