QA Change Control Specialist II - Drive GMP Excellence

American Regent; New Albany (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

American Regent is seeking a QA Change Control Specialist II to drive change control lifecycle activities in a regulated manufacturing setting in the United States. You will review change controls, coordinate with Operations, QC, and R&D, and ensure cGMP compliance as part of a dedicated Change Control Group.

The role requires a bachelor’s degree in a science field and at least 3 years in QA or related areas, with strong regulatory knowledge and excellent communication skills.

Qualifications

• Bachelor’s Degree in science-related discipline strongly preferred.
• Minimum 3 years experience in Quality Assurance or related field.
• FDA regulations knowledge strongly preferred.
• Strong organizational and communication skills.

Responsibilities

• Review and approve change controls and related documents.
• Coordinate with cross-functional teams to gather information.
• Maintain electronic document management and training.
• Prepare monthly metrics and Annual Product Review inputs.
• Provide post-implementation support and regulatory readiness.

Skills

Analytical thinking

Critical thinking

Regulatory knowledge

Attention to detail

Written & oral communication

Team collaboration

MS Office (Word/Excel/PowerPoint)

GxP awareness

Education

Bachelor's Degree in science or related discipline

Tools

Microsoft Word

Excel

Access

Visio

PowerPoint

Job description

American Regent is seeking a QA Change Control Specialist II to drive change control lifecycle activities in a regulated manufacturing setting in the United States. You will review change controls, coordinate with Operations, QC, and R&D, and ensure cGMP compliance as part of a dedicated Change Control Group.

The role requires a bachelor’s degree in a science field and at least 3 years in QA or related areas, with strong regulatory knowledge and excellent communication skills.