GMP Quality Specialist for Pharma Packaging

Sharp Corporation; Macungie (Lehigh County); On-site; USD 85,000 - 105,000; Full time

Job summary

Sharp Packaging Services is seeking a Quality Specialist to provide quality oversight, GMP guidance and support for designated functional areas within Sharp Commercial sites. The role partners with internal teams and may represent Sharp Quality in customer interactions, driving GMP initiatives and continuous improvement through data analysis, training and coaching.

The ideal candidate will have knowledge of FDA regulations pertaining to Pharmaceutical/Pharmaceutical Packaging Operations, with a

Qualifications

• Bachelor's degree preferred with 1–3 years related experience or Associate degree with 3–5 years related experience.
• Experience in inspection of pharmaceutical or related industry is required.

Responsibilities

• Actively participate in non-conformance investigations with robust root cause analysis and CAPA planning.
• Review and approve quality documentation such as forms, work instructions, shipping requirements, specifications.
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.
• Support customer relationships related to Quality as needed.
• Identify and resolve potential risks; implement process control and improvement methods.
• Perform periodic review of room/equipment logbooks and Master Packaging Records for accuracy.
• Provide regulatory and customer audit support and assist with observation responses.

Skills

Quality oversight

GMP knowledge

FDA regulations

Root cause analysis

CAPA planning

Documentation review

Education

Bachelor's degree in related field

Associate degree + 3–5 years related experience

Tools

QMS/QA systems

Job description

Sharp Packaging Services is seeking a Quality Specialist to provide quality oversight, GMP guidance and support for designated functional areas within Sharp Commercial sites. The role partners with internal teams and may represent Sharp Quality in customer interactions, driving GMP initiatives and continuous improvement through data analysis, training and coaching.

The ideal candidate will have knowledge of FDA regulations pertaining to Pharmaceutical/Pharmaceutical Packaging Operations, with a