Pharma Quality Specialist — GMP & CAPA Leader (1st Shift)

Sharp Services, LLC; Pennsylvania; On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Packaging Services is seeking a Quality Specialist (1st Shift) to provide quality oversight, GMP guidance, and make quality decisions within designated areas. You will work closely with internal teams and may represent Sharp Quality in customer interactions.

Responsibilities include supporting GMP initiatives, data analysis, training, and collaboration with stakeholders across sites in Allentown, Macungie and Conshohocken.

Qualifications

• Experience with GMP/QA in pharmaceutical or packaging operations.
• Familiarity with FDA regulations and industry standards.
• Proven ability to drive CAPA and continuous improvement.

Responsibilities

• Participate in non-conformance investigations and root-cause analysis.
• Review and approve quality documentation and forms.
• Support customer relationships related to Quality and regulatory audits.
• Assist with calibration, testing, and inspection scheduling.
• Provide training and coaching to staff on quality processes.

Skills

GMP knowledge

FDA regulations

CAPA

Root cause analysis

QA documentation

Education

Bachelor’s degree in Life Sciences

Associate degree in related field

Job description

Sharp Packaging Services is seeking a Quality Specialist (1st Shift) to provide quality oversight, GMP guidance, and make quality decisions within designated areas. You will work closely with internal teams and may represent Sharp Quality in customer interactions.

Responsibilities include supporting GMP initiatives, data analysis, training, and collaboration with stakeholders across sites in Allentown, Macungie and Conshohocken.