QA Associate

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

About Us

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

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.

Job Specifications

Core Competencies

• Communication
• Continuous Learning
• Customer Service Orientation
• Decision Making
• Integrity
• Teamwork

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 Education

• Bachelor’s degree

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.

Benefits

• health insurance coverage
• life and disability insurance
• retirement savings plans
• paid leave programs
• paid holidays
• paid time off

Many of these benefits are subsidized or fully paid for by the company.