Pharma Operations Specialist - Quality & Batch Compliance

PCI TRGR Penn Pharmaceutical Services Ltd

Philadelphia (Philadelphia County)

In loco

USD 55.000 - 78.000

Tempo pieno

5 giorni fa

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Descrizione del lavoro

PCI Pharma Services in Philadelphia, PA is seeking an Operations Specialist responsible for ensuring cGMP compliance, batch record reviews, and real-time quality improvements on the production floor. The role involves audits of production room documentation, hourly inspections, equipment calibration checks, and mentoring ops staff to drive Right First Time metrics with potential overtime and weekend work.

Candidates should have a High School Diploma and 2–4 years in production or related fields,

Competenze

High School Diploma required; 2–4 years in production, equipment, or process packaging preferred.
Strong analytical, verbal and written communication skills; able to coach and train others.
Must be dependable, proactive about safety, quality, throughput and cost performance.

Mansioni

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 packaged within validated parameters and calibration dates are current.
Review batch records to confirm inspections and non-conformances are addressed.
Conduct periodic checks to confirm hourly inspections meet AQL requirements.
Review sampling pages to ensure samples are taken, labeled, and documented.
Audit production rooms to ensure logbooks and maintenance records are complete.
Confirm packaging functionality (perf, peel, seals, etc.).
Audit safety compliance and PPE usage among production personnel.