Quality GMP Specialist — CAPA & Compliance

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

Job summary

Sharp Packaging Services in Allentown/Lehigh Valley is seeking a Quality Specialist to provide quality oversight, GMP guidance, and support for designated functional areas within Sharp Commercial sites. You will collaborate daily with internal teams and may represent Quality in customer interactions.

The role focuses on supporting GMP initiatives, continuous improvement, data analysis, training, and coaching, with working knowledge of FDA regulations for Pharmaceutical operations.

Qualifications

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

Responsibilities

• Actively participate in non-conformance investigations and CAPA planning.
• Review and approve quality documentation 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 risks and facilitate containment actions with operations leadership.
• Audit internal processes on shop floor and warehouse to ensure compliance.

Skills

GMP knowledge

CAPA processes

QA documentation

Data analysis

FDA regulations

Audit/inspection

Education

Bachelor’s degree preferred

Associates Degree

Tools

QMS software

Microsoft Office

Electronic documentation

Job description

Sharp Packaging Services in Allentown/Lehigh Valley is seeking a Quality Specialist to provide quality oversight, GMP guidance, and support for designated functional areas within Sharp Commercial sites. You will collaborate daily with internal teams and may represent Quality in customer interactions.

The role focuses on supporting GMP initiatives, continuous improvement, data analysis, training, and coaching, with working knowledge of FDA regulations for Pharmaceutical operations.