cGMP Operations Specialist — Quality & Process Improvement

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 34,000 - 44,000; Full time

Job summary

PCI Pharma Services in Philadelphia, PA is seeking an Operations Specialist to oversee cGMP compliant production workflows, batch record review, and real-time quality checks on the 7a-7p (C shift) schedule.

You will mentor operators, verify line readiness, ensure calibration and documentation accuracy, and contribute to continuous improvement initiatives aimed at improving Right First Time metrics and overall production efficiency.

Qualifications

• Must have High School Diploma.
• 2–4 years experience in production, equipment or process.
• Packaging or pharma/biopharma/medical device background preferred.
• Must be willing to work overtime and flexible shifts.

Responsibilities

• Perform operational production room approvals after product and lot changes.
• Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct.
• Ensure equipment is within validated parameters and calibration dates are current.
• Review batch records and hourly inspections; address non-conformances and support AQL.
• Support continuous quality and process improvements on the production floor; mentor operational staff.

Skills

Analytical skills

Verbal and written communication

Listening and coaching

Interpersonal communication

Problem solving

Detail oriented

Organized

Safety focus

Education

High School Diploma

2–4 years relevant experience in production/equipment/process

Packaging/Pharmaceutical/Bio-Pharma/Medical Device background preferred

Job description

PCI Pharma Services in Philadelphia, PA is seeking an Operations Specialist to oversee cGMP compliant production workflows, batch record review, and real-time quality checks on the 7a-7p (C shift) schedule.

You will mentor operators, verify line readiness, ensure calibration and documentation accuracy, and contribute to continuous improvement initiatives aimed at improving Right First Time metrics and overall production efficiency.