QA Associate
About The Position
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. This position is responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.
Requirements
- 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
Responsibilities
- 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.
Benefits
- health insurance coverage
- life and disability insurance
- retirement savings plans
- paid leave programs
- paid holidays
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
