QA Associate

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

Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.

With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.

Position Summary
This position is responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.

POSITION ACCOUNTABILITIES

• Perform packaging line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
• Perform finished product attribute sample inspection and evaluation of finished products’ physical characteristics prior to packaging.
• Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
• Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
• Assist with maintenance of Supplier Quality program, to potentially include performing external audits.
• Assist as required in the stability department, with validation activities, and/or annual report assembly.
• Perform other duties as assigned or requested.

Functional Competencies

• Analytic Problem-Solving
• Change Leadership
• Data Affinity
• Attention to Detail
• Project and Process Management
• Quality Standards and Best Practices
• Rules and Regulations

Minimum Experience

• 5 years’ experience in Quality Assurance

Minimum Field of Expertise

• Computer skills
• Previous work in a regulated environment
• Problem solving skills
• Ability to coordinate multiple tasks in a fast-paced environment
• Ability to read and follow procedures
• Ability to work independently
• Attention to detail
• Excellent interpersonal skills
• Excellent organizational and follow-through skills
• Excellent written and verbal communication skills
• Knowledge of cGMPs
• Must be able to work within a team environment
• Strong organizational skills

The base salary range for this position is$52,000-$70,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.

ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

Job Info

• Job Identification 1406
• Posting Date 06/24/2026, 03:45 PM
• Job Schedule Full time
• Locations 70 Lake Drive, East Windsor, New Jersey, 08520, US