Associate Quality Account I

Responsibilities

• Create, update, and peer review Master Packaging Instructions, forms, and material specifications to ensure compliance with internal and customer requirements.
• Perform batch record reviews of completed and in-process orders to ensure adherence to cGMP and customer standards.
• Serve as the primary Quality Assurance contact for assigned customer accounts and act as a company liaison regarding quality control documentation.
• Identify, track, and resolve document-related issues in collaboration with other departments and customers.
• Facilitate customer meetings and conference calls to provide quality-related information and specific metrics.
• Assist in populating quality metrics and key performance indicators (KPIs) for team performance.
• Initiate and investigate quality deviations and supplier non-conformance reports.
• Support the training and mentoring of new Quality Coordinators.

Requirements

• Associate degree in a related field and/or 1-3 years of related experience or training.
• Basic mathematical skills.
• Intermediate computer skills, including the ability to perform complex tasks across various programs.
• Full professional proficiency in speaking, reading, and writing.
• High reasoning skills with the ability to solve practical problems and interpret various forms of instructions.

Preferred Qualifications

• Proven ability to identify and resolve problems in a timely manner.
• Strong decision-making capabilities.
• Excellent time management skills.
• Ability to follow complex instructions and respond effectively to management direction.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between biopharma companies and their patients. We focus on delivering life-changing therapies through operational excellence and an uncompromising commitment to quality.