QA Operations Specialist III / IV

About the role

The QA Operations Specialist will provide QA oversight on the production floor, review documentation, assist with deviations, and serve as a key quality resource to operations teams.

Responsibilities

• Supports manufacturing operations from a Quality perspective
• Reviews batch records
• Assists with deviations, non-conformance, and investigations
• Works cross-functionally with manufacturing teams to make sound quality decisions

Requirements

• 3+ years of GMP-regulated pharmaceutical, biotech, or related manufacturing experience
• Experience supporting manufacturing operations from a Quality perspective
• Batch record review experience
• Deviation, non-conformance, or investigation experience
• Strong understanding of cGMP requirements
• Ability to make sound quality decisions and work cross-functionally with manufacturing teams
• Experience with quality systems and electronic documentation platforms preferred

Qualifications

• Must be able to work onsite

Skills

• Strong understanding of cGMP requirements
• Ability to make sound quality decisions
• Work cross-functionally with manufacturing teams
• Experience with quality systems and electronic documentation platforms

Benefits

• Annual bonus
• Shift differential available where applicable

Pay

• $88K-$102K base salary

Schedule

• Day Shift
• Night Shift
• Senior-Level Night Shift Opportunity