Position Summary:
The Quality Operations Specialist ensures product safety and sterility through oversight, documentation review, and issue resolution, supporting Empower’s mission to provide affordable, innovative medications.

Duties and Responsibilities:

• Oversees manufacturing operations to ensure product sterility, safety, and quality, monitoring personnel and processes with authority to halt operations if needed.
• Reviews Current Good Manufacturing Practice (cGMP) batch records and documentation for accuracy, ensuring compliance with procedures and standards.
• Assists in investigations to identify root causes, implement corrective actions, and resolve quality issues using problem-solving skills.
• Conducts operational checks on cleaning, labeling, and cleanroom layouts, ensuring compliance with environmental monitoring and documentation standards.
• Supports safety, improvement initiatives, and serves as backup for Environmental Monitoring Technician tasks, including gown qualification and media fill proctoring.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills:

• Strong attention to detail, organizational, and prioritization skills, with the ability to multitask effectively while adhering to aseptic and regulatory standards.
• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook) with required experience in sterile and nonsterile manufacturing and knowledge of state and federal regulations.

• Oversees manufacturing operations to ensure product sterility, safety, and quality, monitoring personnel and processes with authority to halt operations if needed.
• Reviews Current Good Manufacturing Practice (cGMP) batch records and documentation for accuracy, ensuring compliance with procedures and standards.
• Assists in investigations to identify root causes, implement corrective actions, and resolve quality issues using problem-solving skills.
• Conducts operational checks on cleaning, labeling, and cleanroom layouts, ensuring compliance with environmental monitoring and documentation standards.
• Supports safety, improvement initiatives, and serves as backup for Environmental Monitoring Technician tasks, including gown qualification and media fill proctoring