Quality Coordinator - cGMP Documentation & Compliance

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services in Philadelphia seeks a Quality Coordinator to support quality activities and drive project success. You will coordinate documentation for production work orders, review batch records for cGMP compliance, and prepare materials for product release.

This role involves reviewing customer specifications and coordinating approvals with internal teams. The position requires a high school education with preferred science-focused college credits, strong organizational skills, and

Qualifications

• High school diploma required; a college degree with a science focus preferred.
• Strong organizational and time-management abilities to meet tight deadlines.
• Proficiency with MS Office and MasterControl; Lean Six Sigma training is a plus.

Responsibilities

• Prepares and distributes required documentation for requested production work orders.
• Performs documentation review of completed orders to ensure cGMP compliance and customer requirements.
• Reviews and interprets customer standards and procedures for batch records, forms and material specs.
• Prepares customer samples for shipment according to shipping instructions.
• Prepares and submits batch records and necessary documentation to customers to facilitate product release.
• Organizes internal and customer approval of batch records and specs.
• Performs record reviews to ensure cGMP and customer compliance.
• Identifies and communicates document-related issues with other departments and customers.
• Acts as customer contact for questions about batch records.
• Initiates supplier non-conformance reports and material control actions.
• Prepares planned deviation requests when needed.
• Adheres to PCI and cGMP policies and procedures.
• Attendance is an essential function of this job.
• May perform duties of Quality Auditor as assigned.

Skills

Organizational skills

Time management

Multi-tasking

Problem solving

Education

Bachelor's degree in science preferred

High school diploma

Tools

MS Office

MasterControl

Job description

PCI Pharma Services in Philadelphia seeks a Quality Coordinator to support quality activities and drive project success. You will coordinate documentation for production work orders, review batch records for cGMP compliance, and prepare materials for product release.

This role involves reviewing customer specifications and coordinating approvals with internal teams. The position requires a high school education with preferred science-focused college credits, strong organizational skills, and