Quality Assurance Specialist

Position Title:

Quality Assurance Specialist Work Location:

Waukegan, IL 60085, Hybrid - Monday & Friday Remote |

Tuesday-Thursday Onsite Assignment Duration:

6

Months Work Arrangement:

Hybrid Position Summary:

The role sits within global Quality Labs organization and supports standardization of quality procedures globally.

Background & Context:

Primary focus is transitioning from separate site-level procedures to globally standardized procedures. The role involves change control activities, document tracking, procedure updates, and global coordination.

Key Responsibilities:

• Support change control activities and change-request processing.
• Perform document tracking, procedure updates, and document coordination.
• Coordinate translation workflows for global procedures maintained in six languages.
• Support quality documentation organization and global alignment.
• Submit documents for translation, track progress, and validate accuracy with site contacts.
• Manage approvals, timelines, and coordination across multiple global sites.
• Perform data entry and updates in relevant systems and trackers.
• Support routine administrative and quality process tasks as assigned.

Qualification & Experience:

• Excellent written and verbal communication skills.
• Strong typing and organizational skills with attention to detail.
• Familiarity with OneVault/Veeva and Microsoft Office Suite preferred.
• Strong change-control and document-processing experience highly preferred.
• Ability to coordinate with global stakeholders across cultures and time zones.
• Experience supporting translation workflows or multilingual documents beneficial.
• Comfort functioning in repetitive, process-driven environments.
• Prior pharmaceutical, biotech, or laboratory experience preferred but not mandatory.
• Ability to work independently with minimal direction while knowing when to seek clarification.