Quality Coordinator (1st Shift) – Pharma Compliance & Docs

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Coordinator for 1st shift at our Philadelphia, PA site. The role supports coordinating quality activities to ensure timely, compliant production and release of materials.

You will review batch records for cGMP compliance, prepare and distribute documentation, and act as a point of contact for questions on batch records while supporting continuous improvement and adherence to PCI policies.

Qualifications

• High school education with exposure to cGMP environments is expected.
• A college degree with a scientific focus is preferred.
• Strong organizational, time management and multitasking skills are essential.
• Proficiency with MS Office and Master Control; ability to create and interpret data tables and charts; Lean Six Sigma training is a plus.

Responsibilities

• Prepare and distribute required documentation for requested production work orders.
• Perform documentation review of completed orders to ensure cGMP compliance and customer requirements.
• Review customer standards, procedures and specifications for dissemination relative to batch records and material specs.
• Prepare customer samples for shipment according to approved shipping instructions.
• Submit batch records and documentation to customers to facilitate product release.
• Organize internal and customer approval of batch records and specs.
• Review records to ensure compliance with cGMP and customer requirements.
• Identify, communicate, track and resolve document-related issues with other departments and customers.
• Serve as a customer contact for batch record questions and comments.
• Initiate supplier non-conformance reports and implement material control actions.
• Prepare planned deviation requests when needed.
• Adhere to PCI and cGMP policies and regulations.
• Attendance is an essential function of this job.
• May perform duties of Quality Auditor as assigned.

Skills

Organizational skills

Time management

MS Office

Master Control

Lean Six Sigma

Problem solving

Education

High school diploma

Science degree preferred

Tools

Master Control

MS Office

Job description

PCI Pharma Services is seeking a Quality Coordinator for 1st shift at our Philadelphia, PA site. The role supports coordinating quality activities to ensure timely, compliant production and release of materials.

You will review batch records for cGMP compliance, prepare and distribute documentation, and act as a point of contact for questions on batch records while supporting continuous improvement and adherence to PCI policies.