QA Associate, GMP & Packaging Compliance

ANI Pharmaceuticals, Inc.; 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 programs

Paid holidays

Paid time off

Job summary

ANI Pharmaceuticals, Inc. is seeking a Quality Assurance professional to support Manufacturing and Packaging operations, ensuring cGMP compliance and adherence to SOPs. The role requires a bachelor's degree and at least 5 years in a regulated QA environment.

The position emphasizes detailed inspection, sample testing, and collaboration across teams to maintain product quality and regulatory standards in a fast-paced facility in New Jersey.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 5 years of experience in Quality Assurance in a regulated environment.
• Strong knowledge of cGMPs and regulatory requirements.

Responsibilities

• Perform packaging line inspection/audits to ensure SOPs and cGMP compliance.
• Inspect finished product attributes and evaluate physical characteristics before packaging.
• Conduct annual retain sample inspections and manage reserve samples.
• Monitor GMP areas for gowning and cleanliness to meet industry standards.
• Assist with Supplier Quality program and potential external audits.
• Assist in stability/validation activities and annual report assembly.
• Perform other duties as assigned.

Skills

Quality Assurance

cGMP compliance

Documentation

Inspection

Attention to Detail

Education

Bachelor's degree

Job description

ANI Pharmaceuticals, Inc. is seeking a Quality Assurance professional to support Manufacturing and Packaging operations, ensuring cGMP compliance and adherence to SOPs. The role requires a bachelor's degree and at least 5 years in a regulated QA environment.

The position emphasizes detailed inspection, sample testing, and collaboration across teams to maintain product quality and regulatory standards in a fast-paced facility in New Jersey.