Location
Hoover, AL, United States
Posted
July 25, 2026
Job Description
Description
The Quality Manager is responsible for overseeing and maintaining the quality assurance (QA) and quality control (QC) programs in a 503B outsourcing facility. This role ensures compliance with FDA, cGMP (Current Good Manufacturing Practices), USP <797>, USP <800>, and DEA regulations. The Quality Manager will lead audits, manage investigations, and drive continuous improvement initiatives to uphold product safety, efficacy, and sterility
Job Activities and Responsibilities:
Ensure compliance with FDA 21 CFR Part 210 & 211, USP <797>, USP <800>, and cGMP requirements.
Demonstrate proficiency and follow Standard Operating Procedures related to sterile compounding, cleanroom operations and quality control.
Develop and implement quality assurance procedures to ensure the quality of compounded medication, including but not limited to the materials, storage, preparation, and dispensing of compounded medication.
Supervise environmental monitoring (EM), sterilit...
The Quality Manager is responsible for overseeing and maintaining the quality assurance (QA) and quality control (QC) programs in a 503B outsourcing facility. This role ensures compliance with FDA, cGMP (Current Good Manufacturing Practices), USP <797>, USP <800>, and DEA regulations. The Quality Manager will lead audits, manage investigations, and drive continuous improvement initiatives to uphold product safety, efficacy, and sterility
Job Activities and Responsibilities:
Ensure compliance with FDA 21 CFR Part 210 & 211, USP <797>, USP <800>, and cGMP requirements.
Demonstrate proficiency and follow Standard Operating Procedures related to sterile compounding, cleanroom operations and quality control.
Develop and implement quality assurance procedures to ensure the quality of compounded medication, including but not limited to the materials, storage, preparation, and dispensing of compounded medication.
Supervise environmental monitoring (EM), sterilit...