Job Title: QC Manager

Work Location: Dallas-Fort Worth, Texas

Summary:
The Quality Control Manager manages, plans, and directs the Quality Control and Microbiology laboratories to ensure lab testing provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations. This role ensures products meet acceptable quality standards.

Responsibilities:

• Manages Quality Control in QC Chemistry/QC Microbiology
• Evaluates, updates, and approves all documents used by Chemistry/Microbiology
• Tracks all initiated DCNs
• Updates all systems to improve testing efficiencies and work flow
• Oversees safety program for Chemistry
• Approves OOS investigations, root cause, and CAPA
• Reviews and approves validation protocols
• Conducts performance evaluations for Chemists and Microbiologists
• Assures laboratory is in audit ready state at all times
• Creates and maintains job descriptions for Chemists and Microbiologist positions
• Staff development for Chemist I Chemist II and Microbiologist I and II
• Approvals for in-process, finished product, stability, raw material testing releases
• Approves for all labels and package product specifications
• Approves all report and trends
• Designs lab workspaces

Qualifications:

• Bachelors of Science in Chemistry, Biology, or related discipline is required
• At least 5 years of previous practical lab work experience in pharmaceutical and/or dietary supplements required
• Strong knowledge of properties of formulations and ability to use knowledge gained from scientific research to develop methods, SOP's, and procedures
• Must have knowledge of Regulatory Compliance - FDA, cGMP, and cGLP

Published Category: Quality & Validation