Quality Coordinator

Responsibilities

• Prepare and distribute required documentation for production work orders
• Perform documentation and records review of completed orders to ensure compliance with cGMP and customer requirements
• Create and update batch records, forms, and material specifications
• Submit batch records, accountability reports, and necessary documentation to customers to facilitate product release
• Identify, communicate, track, and resolve document-related issues with other departments and customers
• Function as a customer point of contact for questions pertaining to batch documentation
• Assist with providing quality-related metrics
• Perform finished product batch release of approved production lots
• Review and interpret customer standards, procedures, and specifications

Requirements

• High School Diploma or GED
• 2 years of experience in Operations/Quality or providing support in an office or manufacturing environment
• Basic mathematical skills and ability to interpret technical instructions in math or diagram form
• Intermediate computer skills with the ability to perform complex tasks across various programs
• Full professional English proficiency (speaking, reading, and writing)
• Strong reasoning skills to define problems, collect data, and draw valid conclusions

Preferred Qualifications

• Ability to follow instructions and respond effectively to management direction
• Proven ability to identify and resolve problems in a timely manner
• Strong attention to detail and ability to maintain a professional manner

Benefits

• Competitive salary and eligibility for an annual performance bonus
• Paid time off
• Health insurance coverage, including dental and vision
• Flexible spending account
• 401(k) retirement plan

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.