Operations Specialist - GMP & Continuous Improvement

pciservices; Philadelphia (Philadelphia County); On-site; USD 42,000 - 60,000; Full time

Job summary

PCI Services in Philadelphia, PA seeks an Operations Specialist to oversee production floor compliance and real-time batch review. You will audit documentation, ensure sampling, verify equipment parameters and maintain 5S, cGMP adherence and data integrity across batch records.

The role emphasizes proactive problem solving, coaching of operators, and participation in improvement teams to drive Right First Time metrics.

Qualifications

• High School Diploma required.
• 2-4 years relevant experience in production, equipment and/or process.
• Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background preferred.

Responsibilities

• Perform operational production room approvals after product and lot changes.
• Verify first piece inspection to ensure finished goods code, format, and expiration date are correct.
• Ensure equipment is packaged within validated parameters and calibration dates are within specifications.

Skills

Analytical skills

Verbal & written communication

Teamwork

Education

High School Diploma

Tools

MS Office

ERP systems

Job description

PCI Services in Philadelphia, PA seeks an Operations Specialist to oversee production floor compliance and real-time batch review. You will audit documentation, ensure sampling, verify equipment parameters and maintain 5S, cGMP adherence and data integrity across batch records.

The role emphasizes proactive problem solving, coaching of operators, and participation in improvement teams to drive Right First Time metrics.