QA Associate — cGMP Packaging & Compliance

ANI Pharmaceuticals; East Windsor Township (NJ); On-site; USD 52,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

Retirement savings plans

Paid leave & holidays

Paid time off

Job summary

ANI Pharmaceuticals in East Windsor, NJ is seeking a Quality Assurance professional to support Manufacturing and Packaging operations to ensure cGMP compliance.

The role conducts packaging line audits, finished product inspections, and retain sample management, while supporting supplier quality and stability activities. Candidates should have 5+ years in QA, strong attention to detail, and excellent communication; base salary ranges with comprehensive benefits.

Qualifications

• 5+ years of experience in Quality Assurance.
• Experience in a regulated environment.
• Ability to read and follow procedures.
• Ability to work independently and in a team.
• Excellent interpersonal, organizational and communication skills.
• Knowledge of cGMPs.

Responsibilities

• Inspect packaging lines and ensure compliance with SOPs and cGMPs.
• Inspect finished product samples for physical characteristics prior to packaging.
• Inspect and manage retain samples stored in reserve room.
• Monitor GMP areas for cleanliness and proper gowning per CFR21 Subpart A.
• Assist with Supplier Quality program including external audits.
• Assist stability activities, validation, and annual report assembly.
• Perform other duties as assigned.

Skills

Analytical skills

Change Leadership

Data affinity

Attention to detail

Project management

Quality standards

Regulatory knowledge

Job description

ANI Pharmaceuticals in East Windsor, NJ is seeking a Quality Assurance professional to support Manufacturing and Packaging operations to ensure cGMP compliance.

The role conducts packaging line audits, finished product inspections, and retain sample management, while supporting supplier quality and stability activities. Candidates should have 5+ years in QA, strong attention to detail, and excellent communication; base salary ranges with comprehensive benefits.