QA Associate

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. 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

The following are essential job 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. 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.

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