Quality Assurance Generalist

Job Description

Quality Assurance Generalist | Fagron

The Tone:
This is a full-time role at Fagron. Fagron, a global market leader in personalized medicine with over 3,000 employees worldwide, is dedicated to optimizing and innovating personalized pharmaceutical solutions to improve lives. This role is crucial for ensuring the quality and compliance of compounded products through meticulous quality assurance activities, maintaining proper controls throughout manufacturing, processing, packaging, and warehousing.

The TL;DR
• Role: Early Career
• Type: Full-time (Mon-Fri 10a-6:30p)
• Location: In-person
• Pay: $55000–$70000 yearly
• Mission: This person will ensure proper controls are followed and maintained across all stages of compounded product manufacturing to uphold quality and compliance.
• Tech Stack: MS Office (Word, Excel), MasterControl

What You’ll Actually Do
• Quality Assurance: Support the execution of product Batch Records and associated manufacturing and Quality related systems for compounding processes.
• Compliance Oversight: Ensure daily adherence to all established requirements for compounded products and the systems supporting their compounding.
• Documentation Review: Review and approve manufacturing batch records, labels, and other batch-related documentation.
• Audit Participation: Assist with internal, corporate, third-party, and federal/state inspections and audits.
• Performance Reporting: Provide contributing information on measures of local quality system effectiveness, such as documentation errors.

The Must-Haves
• Background: College Degree or a High school diploma or equivalent with cGMP experience in a pharmaceutical manufacturing company.
• Experience: Prior cGMP experience in a pharmaceutical manufacturing company or similar environment is required.
• Skills: Proficient in MS Office programs (Word, Excel), strong attention to detail, focus on quality and accuracy, and ability to collaborate professionally.
• Bonus: Experience with aseptic technique, cGMP document review, and MasterControl.