QA Change Control Specialist II: Drive GMP Change Management

American Regent, Inc.; New Albany (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

American Regent Inc. in New Albany, OH, is seeking a QA Change Control Specialist II to join the Change Control Group. You will participate in all aspects of the change lifecycle, from initiation to implementation, ensuring compliance with cGMPs and company SOPs.

The role emphasizes coordinating with multiple departments, maintaining controlled documents, and developing training around the Change Control process. Strong analytical, communication, and teamwork skills are essential.

Qualifications

• Bachelor's Degree in science-related discipline required, with strong preference.
• Minimum 3 years in Quality Assurance or related field.
• Proficient in Microsoft Word, Excel, Access, Visio, PowerPoint, and email.
• Strong analytical, critical thinking, organizational and communication skills.
• Knowledge of FDA regulations preferred.

Responsibilities

• Review and approve change controls as designee.
• Coordinate with departments to obtain supporting information and facilitate review/approval/implementation.
• Assist users with the electronic document management system and train personnel.
• Prepare monthly metrics related to change control and document control processes.
• Develop, revise SOPs related to the Change Control process.
• Support regulatory inspections by providing requested documents and SME access.

Skills

Analytical thinking

Communication skills

Teamwork

Attention to detail

Time management

Education

Bachelor's Degree in science related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Visio

PowerPoint

Job description

American Regent Inc. in New Albany, OH, is seeking a QA Change Control Specialist II to join the Change Control Group. You will participate in all aspects of the change lifecycle, from initiation to implementation, ensuring compliance with cGMPs and company SOPs.

The role emphasizes coordinating with multiple departments, maintaining controlled documents, and developing training around the Change Control process. Strong analytical, communication, and teamwork skills are essential.